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 | Zenith Dissection Endovascular System |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | WILLIAM COOK EUROPE APSsandet 6, Dk-4632bjaeverskov PMA NumberP180001 Supplement NumberS004 Date Received03/18/2022 Decision Date04/14/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-18 |
| Decision Date | 2022-04-14 |
| PMA | P180001 |
| Supplement | S004 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | WILLIAM COOK EUROPE APS sandet 6, Dk-4632 bjaeverskov PMA NumberP180001 Supplement NumberS004 Date Received03/18/2022 Decision Date04/14/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement an Additional Seal On One Side Of The Zenith Dissection Endovascular Graft Primary Packaging And New Specifications For The Position Of An Already Applied Seal On The Opposite Side |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180001 | Original Filing | |
| S006 | 2022-06-06 | Real-time Process |
| S005 | 2022-05-05 | Special (immediate Track) |
| S004 | 2022-03-18 | Special (immediate Track) |
| S003 | 2021-11-15 | 30-day Notice |
| S002 | 2020-10-02 | Normal 180 Day Track No User Fee |
| S001 | 2019-10-01 | Normal 180 Day Track No User Fee |