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Device | OVATION ABDOMINAL STENT GRAFT SYSTEM PLATFORM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Endologix, LLC 3910 Brickway Blvd Santa Rosa, CA 95403 |
PMA Number | P120006 |
Supplement Number | S026 |
Date Received | 07/28/2016 |
Decision Date | 08/24/2016 |
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 Implementation of an update to the iliac stent graft sheath loading fixture configuration and a revision to the corresponding loading process instructions to include the updated fixture configuration; 2) Implementation of the modified maximum loading force specification and in-sheath force specification of the Ovation iX Iliac Limb Stent Graft; and3) Implementation of the modified crimp diameter for the 14 mm Ovation iX Iliac Stent Graft. |