|
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 | S007 |
Date Received | 11/16/2023 |
Decision Date | 12/14/2023 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement addition of a different form of the inner PTFE liner material used in the Zenith Introduction Systems |