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Edwards Sapien Xt Transcatheter Heart Valve (thv)

FDA UDI

Class III (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) FDA UDI
Generic Name
Aortic transcatheter heart valve bioprosthesis, stent-like framework FDA UDI
Device Name
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (29MM) FDA UDI
Model / Reference
9300TFX FDA UDI
Description
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (29MM) FDA UDI

Identifiers

Catalog Number
9300TFX29A FDA UDI
Primary DI / UDI-DI
00690103193176 FDA UDI
PMA Number
P130009 FDA UDI
FDA Product Code
NPT FDA UDI
NPV FDA UDI
GMDN Term
Aortic transcatheter heart valve bioprosthesis, stent-like framework FDA UDI

Classification

Device Class
Class III 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Aortic transcatheter heart valve bioprosthesis, stent-like frameworkPulmonary transcatheter heart valve bioprosthesis

Edwards Sapien Xt Transcatheter Heart Valve (thv) by Edwards Lifesciences LLC — Class III — 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

P130009 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 3f1bfa88-71f1-47b1-be75-580715eacfdd 36 fields · synced Jun 8, 2026