Catalog Number

9630TF23A

Brand Name

SAPIEN 3 Ultra Delivery System

Version/Model Number

9630TF23

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P140031,P140031,P140031

Product Code

NPT

Product Code Name

Aortic Valve, Prosthesis, Percutaneously Delivered

Public Device Record Key

6e952784-3615-4dea-b8ea-a0eb6ec924e4

Public Version Date

July 04, 2022

Public Version Number

6

DI Record Publish Date

January 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-