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Device | MEDTRONIC VASCULAR ENDURANT 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 | S052 |
Date Received | 05/19/2016 |
Decision Date | 06/16/2016 |
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 inspection step to the rear handle assembly process; 2) narrowing of the thread radius dimension tolerances on the handle lock; and 3) addition of detailed cleaning instructions at supplier for the moulding equipment. |