|
Device | VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P100040 |
Supplement Number | S016 |
Date Received | 01/31/2014 |
Decision Date | 02/26/2014 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00413231
|
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement DUPLICATE THE STENT GRAFT WASHING PROCESS AND THE INTERIM PACKAGING/ SHIPMENT OF STENT GRAFTS FROM ONE APPROVED STENT GRAFT MANUFACTURING SITE TO ANOTHER. |
Post-Approval Study | Show Report Schedule and Study Progress |