OVATION ABDOMINAL STENT GRAFT SYSTEM, OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, OVATION IX ILIAC STENT GRAFT
FDA premarket approval P120006/S021 · decided 2015-08-07
Approval details
- PMA number
- P120006
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OVATION ABDOMINAL STENT GRAFT SYSTEM, OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, OVATION IX ILIAC STENT GRAFT
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2015-07-10
- Decision date
- 2015-08-07
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- CHANGE TO THE PYROGEN SAMPLING PLAN FOR FINISHED PRODUCT RELEASE OF ETHYLENE OXIDE (EO) STERILIZED PRODUCT IN THE OVATION STENT GRAFT/DELIVERY SYSTEM FAMILY.
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