TRIVASCULAR, INC OVATION ABDOMINAL STENT GRAFT SYSTEM, TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
FDA premarket approval P120006/S014 · decided 2014-09-09
Approval details
- PMA number
- P120006
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TRIVASCULAR, INC OVATION ABDOMINAL STENT GRAFT SYSTEM, TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2014-07-22
- Decision date
- 2014-09-09
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE FILL POLYMER KIT.
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