|
Device | ENDURANT/ENDURANT II/ ENDURANT IIS STENT GRAFT |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P100021 |
Supplement Number | S057 |
Date Received | 08/17/2016 |
Decision Date | 02/01/2017 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updated in-process sampling requirements and to remove redundant inspections. |