| 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 PRIME ABDOMINAL STENT GRAFT SYSTEM |
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| Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
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| Applicant | Endologix, LLC
3910 Brickway Blvd
Santa Rosa, CA 95403 |
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| PMA Number | P120006 |
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| Supplement Number | S001 |
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| Date Received | 10/24/2012 |
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| Decision Date | 12/11/2012 |
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| Product Code |
MIH |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Real-Time Process |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR MODIFICATIONS TO THE ENDOVASCULAR SYSTEM, MAINLY THE DELIVERY SYSTEM, TO IMPROVE THE EASE-OF-USE DURING DEPLOYMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM AND IS INDICATED FOR TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC ANEURYSMS HAVING THE VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING: 1) ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES AND/OR ACCESSORIES; 2) NON-ANEURYSMAL PROXIMAL AORTIC NECK: A) WITH A LENGTH OF AT LEAST 7 MM PROXIMAL TO THE ANEURYSM, B) WITH AN INNER WALL DIAMETER OF NO LESS THAN 16 MM AND NO GREATER THAN 30 MM, AND C) WITH AN AORTIC ANGLE OF <= 60 DEGREE IF PROXIMAL NECK IS >= 10 MM AND <= 45 DEGREES IF PROXIMAL NECK IS <= 10 MM. 3) ADEQUATE DISTAL ILIAC LANDING ZONE: A) WITH A LENGTH OF AT LEAST 10 MM, AND B) WITH AN INNER WALL DIAMETER OF NO LESS THEN 8 MM AND NO GREATER THAN 20 MM. |
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