This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Implementation of the use of an alternate polytetrafluoroethylene (ptfe) aqueous-based formulation for coating the processing mandrels used as manufacturing aids during the manufacturing of gore cexc components
Device | Gore Excluder Conformable AAA Endoprosthesis |
Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
Applicant | W. L. Gore And Associates, Inc. |
Date Received | 2021-01-22 |
Decision Date | 2021-02-01 |
PMA | P200030 |
Supplement | S001 |
Product Code | MIH |
Advisory Committee | Cardiovascular |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | W. L. Gore And Associates, Inc. 32360 N. North Valley Parkway phoenix, AZ 85085 |
Supplement Number | Date | Supplement Type |
---|---|---|
P200030 | Original Filing | |
S001 | 2021-01-22 | 30-day Notice |