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 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P200030 | | Original Filing |
| S010 |
2022-09-06 |
30-day Notice |
| S009 |
2022-08-03 |
30-day Notice |
| S008 |
2022-06-28 |
30-day Notice |
| S007 |
2022-01-20 |
30-day Notice |
| S006 |
2021-11-17 |
30-day Notice |
| S005 |
2021-10-29 |
30-day Notice |
| S004 |
2021-09-07 |
30-day Notice |
| S003 |
2021-05-10 |
30-day Notice |
| S002 |
2021-04-06 |
30-day Notice |
| S001 |
2021-01-22 |
30-day Notice |
NIH GUDID Devices