|
Device | MEDTRONIC VASCULAR ANEURX STENT 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 | S019 |
Date Received | 06/06/2005 |
Decision Date | 06/24/2005 |
Withdrawal Date
|
12/20/2013 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO ADD AN ADDITIONAL TENSILE TEST OF THE DELIVERY SYSTEM DURING THE DEVICE MANUFACTURING PROCESS. |