|
Device | MEDTRONIC VASCULAR 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 | S014 |
Date Received | 11/18/2009 |
Decision Date | 12/17/2009 |
Withdrawal Date
|
05/10/2016 |
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 ADDITION OF ALTERNATE ADHESIVE APPLICATION EQUIPMENT AND AN IN-PROCESS VISUAL INSPECTION. |