Catalog Number

-

Brand Name

respistim R Stimulation Lead

Version/Model Number

3102

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

P160039

Product Code

PSR

Product Code Name

Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

Public Device Record Key

033ff60c-80f7-451e-91b3-3b1a3d6829c2

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-