|
Device | ANEURX AAADVANTAGE STENT GRAFT |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 UNOCAL PLACE SANTA ROSA, CA 95403-1774 |
PMA Number | P990020 |
Supplement Number | S026 |
Date Received | 06/04/2007 |
Decision Date | 07/03/2007 |
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 IMPLEMENTATION OF AN INSPECTION FIXTURE TO AID IN THE CURRENT INSPECTION PROCESS TO CONFIRM BOND INTEGRITY. |