Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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 | S042 |
Date Received | 01/10/2012 |
Decision Date | 04/13/2012 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) LABELING. THE LABELING CHANGES INVOLVED RECOMMENDATIONS TO USERS REGARDING MAINTAINING HEMOSTASIS, USE OF FLUOROSCOPY AND TRIGGER WIRE RELEASE, AND AN ALTERNATIVE SUPRARENAL DEPLOYMENT SEQUENCE. |
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