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Heartware, Inc. Registered Devices

Listing registered devices, PMA filings, and compliance records for Heartware, Inc..

enforcement STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101 ID: Z-0476-2024
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enforcement HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102 ID: Z-0477-2024
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enforcement 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN ID: Z-0480-2024
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enforcement HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205 ID: Z-0482-2024
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enforcement HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 ID: Z-0475-2024
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enforcement PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP ID: Z-0481-2024
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enforcement PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104 ID: Z-0479-2024
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enforcement PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103 ID: Z-0478-2024
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enforcement PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU ID: Z-0483-2024
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enforcement HeartWare Model 1102 ID: Z-0744-2023
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enforcement HeartWare HVAD Pump Kit, REF 1103 ID: Z-0745-2023
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enforcement HeartWare HVAD Pump Kit, REF MCS1705PU ID: Z-0750-2023
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enforcement HeartWare HVAD Pump Kit, REF 1104CA-CLIN ID: Z-0747-2023
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enforcement HeartWare Model 1101 ID: Z-0743-2023
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enforcement HeartWare HVAD Pump Kit, REF 1104 ID: Z-0746-2023
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enforcement HeartWare HVAD Pump Kit, REF 1104JP ID: Z-0748-2023
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enforcement HeartWare Model 1100 ID: Z-0742-2023
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enforcement HeartWare HVAD Pump Kit, REF 1205 ID: Z-0749-2023
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enforcement HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System is designed for in-hospital and out-of-hospital settings, including transportation via fixed-wing aircraft or helicopter. ID: Z-1887-2016
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enforcement HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned. ID: Z-1428-2020
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enforcement Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned. ID: Z-0067-2019
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enforcement HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned. ID: Z-2072-2021
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enforcement HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned. ID: Z-1427-2020
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enforcement HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech ID: Z-1993-2023
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enforcement HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE ID: Z-1512-2022
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enforcement HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter ID: Z-0005-2017
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enforcement Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an alternative to transplantation as destination therapy (DT) for patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD Pump Controller is a microprocessor unit that controls and manages HeartWare System operation. It sends power and operating signals to the blood pump and collects information from the pump. The controller requires two power sources for safe operation: either two batteries, or one battery and an AC adapter or DC adapter. While active, patients will typically use two batteries. While relaxing or sleeping, patients should use power from an electrical outlet (AC adapter) because it provides power for an unlimited period of time. The HeartWare Battery Charger is part of the HeartWare Ventricular Assist System (HVAD). Patients receive 4 total batteries with their system along with a battery charger and are instructed to have spare, fully charged batteries always available. The battery charger can charge up to 4 batteries at a time using 4 charging bays. Each battery slides into a bay and is connected to the battery charger. ID: Z-0582-2019
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enforcement Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125 ID: Z-2058-2020
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enforcement Heartware HVAD Pump Implant Kit, Product (REF) Number 1104 ID: Z-2056-2020
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enforcement Heartware HVAD Pump Implant accessories, Product (REF) Number 1153 ID: Z-2059-2020
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enforcement Heartware HVAD Pump Implant Kit, Product (REF) Number 1103 ID: Z-2055-2020
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enforcement Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP ID: Z-2057-2020
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enforcement Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE ID: Z-1340-2021
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enforcement Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511IL, 1511IN, 1511IT, 1511JP, 1511MY, 1520CLIN-AU, 1520CLIN-DE, 1520CLIN-GB, 1520JP, 1520US, 1521AU, 1521BR, 1521CA, 1521CH, 1521DE, 1521GB, 1521IL, 1521IN, 1521IT, 1521JP, 1521KR, 1521TW, 1521US, 1522CA, 1522CA-CLIN ID: Z-1341-2021
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enforcement HeartWare HVAD Implant Kit, REF 1104JP ID: Z-2194-2021
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enforcement Medtronic HVAD Pump Implant Kits ID: Z-2478-2021
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enforcement HeartWare Ventricular Assist Device (HVAD) System ID: Z-0726-2022
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enforcement HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH ID: Z-1106-2022
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enforcement HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0 ID: Z-1105-2022
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enforcement Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR ID: Z-1336-2021
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enforcement Medtronic HVAD Monitor Data Cable, Product Number: 1575 ID: Z-1339-2021
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enforcement Medtronic HVAD Alarm Adapter, Product Number: 1450 ID: Z-1338-2021
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enforcement Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware HVAD controller DC Adapter Model 1440. Heartware HVAD data cable - monitor Model 1575. Heartware HVAD battery pack Models 1650, 1650CA-CLIN, and 1650DE. Heartware HVAD patient pack Model 1475. Heartware HVAD waist pack Models 2050, 2050IL, and 2050US. Heartware HVAD shoulder pack Models 2060, 2060IL, and 2060US. ID: Z-1438-2021
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enforcement Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware HVAD controller DC Adapter Model 1440. Heartware HVAD data cable - monitor Model 1575. Heartware HVAD battery pack Models 1650, 1650CA-CLIN, and 1650DE. Heartware HVAD patient pack Model 1475. Heartware HVAD waist pack Models 2050, 2050IL, and 2050US. Heartware HVAD shoulder pack Models 2060, 2060IL, and 2060US. ID: Z-1469-2021
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enforcement HeartWare HVAD Outflow Graft, REF MCS1725OG ID: Z-2196-2021
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enforcement HeartWare HVAD Implant Kit, REF MCS1705PU ID: Z-2195-2021
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enforcement HeartWare HVAD Pump Implant Kit, REF 1125 ID: Z-2190-2021
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enforcement Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US 2. Medtronic HVAD Controller DC Adapter, Product Number: 1440 ID: Z-1337-2021
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enforcement Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, 1420JP HVAD AC Adapter Controller, Model Numbers: 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US HVAD DC Adapter Controller: Model Number: 1440 HVAD DATA CABLE 1575- MONITOR, Model Number: 1575 HVAD Battery Pack, Model Numbers: 1650, 1650CA-CLIN, 1650DE HeartWare Patient Pack, Model Number: 1475 HeartWare Waist Pack, Model Numbers: 2050, 2050IL, 2050OUS HeartWare Shoulder Pack, Model Numbers: 2060, 2060IL, 2060OUS The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned. ID: Z-1426-2021
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enforcement HeartWare HVAD Pump Accessories, REF MCS1753AK ID: Z-2197-2021
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enforcement HeartWare HVAD Driveline Extension Cable, REF 100 ID: Z-2192-2021
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enforcement HeartWare HVAD Pump Implant Kit, REF 1104 ID: Z-2189-2021
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enforcement HeartWare HVAD Driveline Extension Cable, REF 100US ID: Z-2193-2021
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enforcement HeartWare HVAD Pump Implant Kit, REF 1153 ID: Z-2191-2021
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enforcement HeartWare HVAD Pump Implant Kit, REF 1103 ID: Z-2188-2021
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enforcement HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit ID: Z-1103-2022
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enforcement HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104 ID: Z-1102-2022
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enforcement HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Instructions For Use (FI) HVAD System Instructions For Use (FI) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Instructions For Use - FI HVAD System Instructions For Use (FI) HVAD System OUS Patient Manual (FI-Finnish) HVAD System Emergency Responder Guide (TR-Turkish) HVAD System Patient Manual (TR-Turkish) HVAD System Patient Manual (TR-Turkish) HVAD System Patient Manual (TR-Turkish) HVAD System Patient Manual (TR-Turkish) HVAD System OUS Instructions For Use (TR-Turkish) ID: Z-1107-2022
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enforcement HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420 ID: Z-1104-2022
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enforcement Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU ID: Z-0946-2021
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