|
Device | ZENITH AAA ENDOVASCULAR GRAFT |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | COOK, INC. 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 |
PMA Number | P020018 |
Supplement Number | S049 |
Date Received | 03/26/2013 |
Decision Date | 04/24/2013 |
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 CHANGES TO THE MANUFACTURING AND QUALITY CONTROL PROCEDURES TO PROVIDE ADDITIONAL INSPECTION STEPS REGARDING THE PROXIMAL BARB ALIGNMENT WITH THE TOP CAP SIDE HOLE AND BARB SOLDERING SPECIFICATION FOR THE DEVICE. |