OVATION ABDOMINAL STENT GRAFT SYSTEM PLATFORM
FDA premarket approval P120006/S026 · decided 2016-08-24
Approval details
- PMA number
- P120006
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OVATION ABDOMINAL STENT GRAFT SYSTEM PLATFORM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2016-07-28
- Decision date
- 2016-08-24
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Implementation of an update to the iliac stent graft sheath loading fixture configuration and a revision to the corresponding loading process instructions to include the updated fixture configuration; 2) Implementation of the modified maximum loading force specification and in-sheath force specification of the Ovation iX Iliac Limb Stent Graft; and3) Implementation of the modified crimp diameter for the 14 mm Ovation iX Iliac Stent Graft.
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