OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
FDA premarket approval P120006/S010 · decided 2014-09-30
Approval details
- PMA number
- P120006
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2014-01-31
- Decision date
- 2014-09-30
- Days to decision
- 242 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR CHANGES TO THE CUSTOMSEAL KIT TO ACHIEVE A SHORTER CURE TIME OF THE FILL POLYMER.
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