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 | Ovation iX Abdominal Stent Graft System |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Endologix, LLC 3910 Brickway Blvd Santa Rosa, CA 95403 |
PMA Number | P120006 |
Supplement Number | S028 |
Date Received | 07/19/2017 |
Decision Date | 10/13/2017 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the use of a thermoformed tray for packaging of the Ovation iX Aortic Body, Iliac Limb, and the associated delivery systems. |
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