|
Device | ANEURX STENT GRAFT WITH XPEDIENT 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 | S014 |
Date Received | 07/14/2003 |
Decision Date | 08/08/2003 |
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 CHANGE IN THE MANUFACTURING PROCESS OF THE ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM WHICH INVOLVES A CHANGE IN THE METHOD OF THE JOINING PROCESS FROM ADHESIVE TO LASER-WELD FOR BOTH THE 16 FR AND 12 FR DELIVERY SYSTEMS. |