Catalog Number

-

Brand Name

CoreValve™ Evolut™ R

Version/Model Number

EVOLUTR-34-US

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

P130021,P130021

Product Code

NPT

Product Code Name

Aortic valve, prosthesis, percutaneously delivered

Public Device Record Key

88a4cf70-44ab-43c0-8a00-e32d74ee08ae

Public Version Date

July 04, 2022

Public Version Number

6

DI Record Publish Date

February 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-