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The Edwards Sapien 3 Valve With Alterra Adaptive Prestent System

FDA UDI

Class Unclassified (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
THE EDWARDS SAPIEN 3 VALVE WITH ALTERRA ADAPTIVE PRESTENT SYSTEM FDA UDI
Generic Name
Pulmonary transcatheter heart valve bioprosthesis FDA UDI
Device Name
ALTERRA ADAPTIVE PRESTENT SYSTEM (US) 40MM X 48MM FDA UDI
Model / Reference
29AP4045 FDA UDI
Description
ALTERRA ADAPTIVE PRESTENT SYSTEM (US) 40MM X 48MM FDA UDI

Identifiers

Catalog Number
29AP4045A FDA UDI
Primary DI / UDI-DI
00690103210866 FDA UDI
PMA Number
P200015 FDA UDI
FDA Product Code
NPV FDA UDI
GMDN Term
Pulmonary transcatheter heart valve bioprosthesis FDA UDI

Classification

Device Class
Unclassified FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Pulmonary transcatheter heart valve bioprosthesis

The Edwards Sapien 3 Valve With Alterra Adaptive Prestent System by Edwards Lifesciences LLC — Class Unclassified — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Pulmonary transcatheter heart valve bioprosthesis.

Cleared under the same submission

P200015 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edwards Lifesciences LLC

Sources (1)

  • FDA UDI 3241c6d4-749c-45b7-94dd-d6c60fe5fb68 36 fields · synced Jun 8, 2026