|
Device | ANEURX AAADVANTAGE STENT GRAFT 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 | S035 |
Date Received | 08/04/2009 |
Decision Date | 09/01/2009 |
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 ALTERNATIVE TESTING FACILITY AND CHANGES TO THE SAMPLING PLAN FOR THE FINISHED DEVICE LAL TESTING. |