|
Device | VALIANT THORACIC STENT GRAFT WITH THE CAPTIVA 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 | S007 |
Date Received | 03/22/2012 |
Decision Date | 08/16/2012 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO AUTOMATE THE INFORMATION MANAGEMENT SYSTEM. |