|
Device | TALENT THORACIC GRAFT SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P070007 |
Supplement Number | S017 |
Date Received | 04/07/2010 |
Decision Date | 04/30/2010 |
Withdrawal Date
|
05/10/2016 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING CHANGES REGARDING OVER SIZING BEYOND CURRENT RECOMMENDATIONS AND THE PLACEMENT OF BARE SPRINGS INSIDE OF COVERED STENT GRAFTS. |