OVATION ABDOMINAL STENT GRAFT SYSTEM
FDA premarket approval P120006/S023 · decided 2016-05-05
Approval details
- PMA number
- P120006
- Supplement
- S023
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OVATION ABDOMINAL STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2016-02-22
- Decision date
- 2016-05-05
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for a change in bottom material for the inner and outer pouch for the AutoInjector.
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