|
Device | TALENT ABDOMINAL STENT GRAFT WITH THE XCELERANT HYDRO DELIVERY SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P070027 |
Supplement Number | S012 |
Date Received | 09/17/2009 |
Decision Date | 10/23/2009 |
Withdrawal Date
|
03/06/2017 |
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 MEDTRONIC CARDIAC SURGERY, MEDTRONIC PERFUSION SYSTEMS, MINNEAPOLIS, MINNESOTA. THE PROPOSED SITE WILL BE PERFORMING REWORK OF PACKAGING AND LABELING. |