|
Device | ZENITH FLEX 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 | S034 |
Date Received | 03/10/2010 |
Decision Date | 03/31/2010 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ADDITION OF MANUFACTURING INSTRUCTIONS TO ASSURE THAT THE PROXIMAL TRIGGER WIRE IS NOT INADVERTENTLY ATTACHED TO BOTH TRIGGER KNOBS OF THE DELIVERY SYSTEM. |