|
Device | TALENT THORACIC STENT 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 | S038 |
Date Received | 01/16/2015 |
Decision Date | 04/05/2016 |
Withdrawal Date
|
05/10/2016 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the following changes to the post-approval study for the device: sponsor proposes to terminate its THRIVE Trial PAS due to the device no longer beingmanufactured or commercially available. |