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.
| Device | GORE® Excluder® Conformable AAA Endoprosthesis |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | W. L. Gore And Associates, Inc.32360 N. North Valley Parkwayphoenix, AZ 85085 PMA NumberP200030 Supplement NumberS007 Date Received01/20/2022 Decision Date02/22/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-01-20 |
| Decision Date | 2022-02-22 |
| PMA | P200030 |
| Supplement | S007 |
| 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 PMA NumberP200030 Supplement NumberS007 Date Received01/20/2022 Decision Date02/22/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement removal Of Cytotoxicity And Infrared Spectroscopy Inspections For Incoming Components |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00733132651078 | P200030 | 000 |
| 00733132650934 | P200030 | 000 |
| 00733132650941 | P200030 | 000 |
| 00733132650958 | P200030 | 000 |
| 00733132650965 | P200030 | 000 |
| 00733132650972 | P200030 | 000 |
| 00733132650989 | P200030 | 000 |
| 00733132650996 | P200030 | 000 |
| 00733132651009 | P200030 | 000 |
| 00733132651016 | P200030 | 000 |
| 00733132651023 | P200030 | 000 |
| 00733132651030 | P200030 | 000 |
| 00733132651047 | P200030 | 000 |
| 00733132651054 | P200030 | 000 |
| 00733132651061 | P200030 | 000 |
| 00733132650927 | P200030 | 000 |