OVATION ABDOMINAL STENT GRAFT SYSTEM
FDA premarket approval P120006/S024 · decided 2016-09-29
Approval details
- PMA number
- P120006
- Supplement
- S024
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OVATION ABDOMINAL STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2016-03-18
- Decision date
- 2016-09-29
- Days to decision
- 195 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for manufacturing sites located at Synergy Health AST, LLC, 9020 Activity Road Suite D, San Diego, California 92126 and Synergy Health AST, LLC, 3200 Lakeville Highway, Suite 120, Petaluma, California 94954, for E-Beam sterilization of the Ovation Abdominal Stent Graft System Platform.
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