|
Device | ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT HYDRO 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 | S046 |
Date Received | 06/14/2011 |
Decision Date | 07/13/2011 |
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 REDUCTION IN THE NUMBER OF IN-PROCESS INSPECTION STEPS IN TWO MANUFACTURING PROCESSES OF THE DELIVERY SYSTEMS. |