OVATION ABDOMINAL STENT GRAFT SYSTEM
FDA premarket approval P120006 · decided 2012-10-05
Approval details
- PMA number
- P120006
- Trade name
- OVATION ABDOMINAL STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2012-04-11
- Decision date
- 2012-10-05
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE OVATION ABDOMINAL STENT GRAFT SYSTEM. THIS DEVICE IS INDICATED FOR TREATMENT OF PATIENTS WITH ABDOMINALAORTIC ANEURYSMS HAVING 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
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