|
Device | ANEURX AAADVANTAGE STONE GRAFT WITH XCELERANT DELIVERY SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 UNOCAL PLACE SANTA ROSA, CA 95403-1774 |
PMA Number | P990020 |
Supplement Number | S027 |
Date Received | 09/27/2007 |
Decision Date | 10/26/2007 |
Withdrawal Date
|
12/20/2013 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement USE (BY THE CURRENT SUPPLIER OF BIFURCATED GRAFT COMPONENTS) OF AN ALTERNATE SUPPLIER OF POLYESTER YARN FOR THE MANUFACTURE OF ALL ANEURX AAADVANTAGE BIFURCATED AND ILIAC LIMB SUBCOMPONENT CONFIGURATIONS. |