|
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 | S005 |
Date Received | 12/19/2008 |
Decision Date | 01/16/2009 |
Withdrawal Date
|
05/10/2016 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT ISOTRON PLC, DAVENTRY, UNITED KINGDOM FOR STERILIZATION OF THE DEVICE. |