Catalog Number

9600TFX29A

Brand Name

EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)

Version/Model Number

9600TFX

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NPT

Product Code Name

Aortic valve, prosthesis, percutaneously delivered

Public Device Record Key

a8a9aa1f-f3a0-4ce2-84d3-79a94e5eedda

Public Version Date

July 04, 2022

Public Version Number

11

DI Record Publish Date

July 05, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-