Catalog Number

8300AB23A

Brand Name

EDWARDS INTUITY ELITE AORTIC VALVE

Version/Model Number

8300AB

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

P150036

Product Code

LWR

Product Code Name

heart-valve, non-allograft tissue

Public Device Record Key

c42e6b75-fbf3-4721-a81b-3aee6f34220e

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 02, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-