PMA P040037S079

Device: GORE VIABAHN ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S079
Product code: NIP
Decision date: 2015-06-02
Classification: Stent, Superficial Femoral Artery
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: CHANGE IN THE HEAT TREATMENT MANUFACTURING PROCEDURE, THE USE OF A NEW CONTAINER CLOSURE SYSTEM, AS WELL AS THE ADDITION OF TWO SUPPLIERS FOR A PROCESSING AID.

Current openFDA PMA Record#

Device: GORE VIABAHN ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S079
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2015-06-02
Decision code: OK30
Date received: 2015-05-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE HEAT TREATMENT MANUFACTURING PROCEDURE, THE USE OF A NEW CONTAINER CLOSURE SYSTEM, AS WELL AS THE ADDITION OF TWO SUPPLIERS FOR A PROCESSING AID.