Ovation iX Abdominal Stent Graft System
FDA premarket approval P120006/S028 · decided 2017-10-13
Approval details
- PMA number
- P120006
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Ovation iX Abdominal Stent Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2017-07-19
- Decision date
- 2017-10-13
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for the use of a thermoformed tray for packaging of the Ovation iX Aortic Body, Iliac Limb, and the associated delivery systems.
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