Catalog Number

P394

Brand Name

PALMAZ Balloon Expandable Stent

Version/Model Number

P394

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

P890017,P890017

Product Code

MAF

Product Code Name

STENT, CORONARY

Public Device Record Key

60e2fb17-d5fb-4a5f-becc-92c574029746

Public Version Date

April 08, 2022

Public Version Number

6

DI Record Publish Date

May 07, 2015

Package DI Number

20705032057346

Quantity per Package

4

Contains DI Package

10705032076241

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-