Catalog Number

-

Brand Name

NA

Version/Model Number

5433V

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 25, 2019

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

-

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

P820003

Product Code

LWP

Product Code Name

Implantable pulse generator, pacemaker (non-CRT)

Public Device Record Key

f55cdd54-a3ab-485e-bed9-18002a214adb

Public Version Date

February 13, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-