Catalog Number

6170

Brand Name

St. Jude Medical Infinity™

Version/Model Number

DBS System

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

P140009

Product Code

MHY

Product Code Name

STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Public Device Record Key

25af487b-5ed8-483c-a52f-fac7a6618a4d

Public Version Date

September 24, 2018

Public Version Number

1

DI Record Publish Date

August 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-