|
Device | ENDURANT, ENDURANT 11, ENDURANT IIS STENT GRAFT SYSTEM AND ENDURANT II AORTO-UNI-ILIAC(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 | S044 |
Date Received | 11/21/2014 |
Decision Date | 12/19/2014 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF A MANUFACTURING AID DURING THE HYDROPHILIC COATING PROCESS. |