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Device | ENDURANT AND ENDURANT II STENT GRAFT SYSTEM, ENDURANT II AORTO-UNI-ILAIAC (AUI) 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 | S040 |
Date Received | 09/03/2014 |
Decision Date | 10/03/2014 |
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 PACKAGING FOR ENDURANT AND ENDURANT II STENT GRAFT SYSTEMS. ADDITIONALLY, A CHANGE IN CONFIGURATION FOR THE E-BEAM STERILIZATION PROCESS. |