OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
FDA premarket approval P120006/S001 · decided 2012-12-11
Approval details
- PMA number
- P120006
- Supplement
- S001
- Supplement type
- Real-Time Process
- Trade name
- OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2012-10-24
- Decision date
- 2012-12-11
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- 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-AN
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