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Edwards Sapien 3 Pulmonic Delivery System (29mm)

FDA UDI

Class Unclassified (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
EDWARDS SAPIEN 3 PULMONIC DELIVERY SYSTEM (29MM) FDA UDI
Generic Name
Pulmonary transcatheter heart valve bioprosthesis FDA UDI
Device Name
SAPIEN 3 PULMONIC DELIVERY SYSTEM - 29MM (US) FDA UDI
Model / Reference
9630PL29A FDA UDI
Description
SAPIEN 3 PULMONIC DELIVERY SYSTEM - 29MM (US) FDA UDI

Identifiers

Catalog Number
9630PL29A FDA UDI
Primary DI / UDI-DI
00690103210873 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

Yes

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

Dimensions & Sizes

Size
Balloon Diameter — 29.0000 Millimeter FDA UDI

Category: Pulmonary transcatheter heart valve bioprosthesis

Edwards Sapien 3 Pulmonic Delivery System (29mm) by Edwards Lifesciences LLC — Class Unclassified — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 d4e073af-1e81-427e-843f-fa58a34d7eff 38 fields · synced Jun 8, 2026