Catalog Number

-

Brand Name

ALTRUA™ 20

Version/Model Number

S205

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

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

N970003

Product Code

LWP

Product Code Name

Implantable pulse generator, pacemaker (non-CRT)

Public Device Record Key

2b4b7f94-6fe0-405b-8fde-9e4def8d42b8

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-