|
Device | COOK ZENITH RENU AAA ANCILLARY 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 | S008 |
Date Received | 01/09/2006 |
Decision Date | 02/09/2006 |
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 MODIFYING THE INSTRUCTIONS FOR USE (IFU) FOR THE COOK ZENITH. RENU AAA ANCILLARY GRAFT TO REINFORCE THE PRECAUTION NOT TO INFLATE THE MOLDING BALLOON IN THE VESSEL OUTSIDE THE GRAFT. |