|
Device | ZENITH FLEX 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 | S007 |
Date Received | 10/17/2005 |
Decision Date | 03/23/2006 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY SUBMISSION FOR THE ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT. |