Ovation iX Abdominal Stent Graft System
FDA premarket approval P120006/S032 · decided 2019-04-24
Approval details
- PMA number
- P120006
- Supplement
- S032
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Ovation iX Abdominal Stent Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2019-03-25
- Decision date
- 2019-04-24
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- to implement a change of the surfactant in the FEP dispersion
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