Edwards SAPIEN 3 transcatheter pulmonic valve delivery system (UDI 9631PL29A)
Manufactured by Edwards Lifesciences LLC
Device Regulatory Overview
The Edwards SAPIEN 3 transcatheter pulmonic valve delivery system (Model/Catalog Number: 9631PL29A) is a medical device manufactured by Edwards Lifesciences LLC. This product is indexed under FDA Product Code / Category Classification NPV within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 9631PL29A
- Product Code / EMDN
- NPV
- Device Name
- Pulmonic Delivery System - 29 mm (Gen 2) (US)
- Database Sync Date
- 2026-08-09 09:04:21
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Edwards SAPIEN 3 transcatheter pulmonic valve delivery system?
The registered manufacturer of record for Edwards SAPIEN 3 transcatheter pulmonic valve delivery system is Edwards Lifesciences LLC.
What is the Primary UDI-DI identifier for Edwards SAPIEN 3 transcatheter pulmonic valve delivery system?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 9631PL29A.
What classification code is assigned to this device?
This device is registered under product classification code NPV.
Similar Classification Devices (NPV)
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