Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Endurant, EndurantII, Endurant lls Stent Graft Systems |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P100021 |
Supplement Number | S065 |
Date Received | 07/14/2017 |
Decision Date | 08/10/2017 |
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 Group the Endurant, Endurant II and Endurant IIs Stent Graft System; and the Valiant Thoracic Stent Graft System with Captivia Delivery System; for routine bacterial endotoxin testing (BET). |
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