|
Device | ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | COOK MEDICAL INCORPORATED Sandet 6 Bjaeverskov 4632 |
PMA Number | P140016 |
Supplement Number | S004 |
Date Received | 12/03/2021 |
Decision Date | 12/22/2021 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for 100% visual QC inspection step for release wires. |