Ovation iX Abdominal Stent Graft System
FDA premarket approval P120006/S029 · decided 2017-09-05
Approval details
- PMA number
- P120006
- Supplement
- S029
- 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
- 2017-08-07
- Decision date
- 2017-09-05
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Add a qualified alternate supplier for Ethylene Oxide (EO) sterilization for the Ovation iX Abdominal Stent Graft System.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.