|
Device | ENDURANT IIS STENT GRAFT SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P100021 |
Supplement Number | S042 |
Date Received | 11/07/2014 |
Decision Date | 11/25/2014 |
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 AN ALTERNATE SUPPLIER FOR THE SECONDARY AND TERTIARY PACKAGINGFOR ENDURANT IIS STENT GRAFT SYSTEMS, AS WELL AS A CHANGE IN CONFIGURATION FOR THE E-BEAM STERILIZATION PROCESS. |