Ovation iX Abdominal Stent Graft System
FDA premarket approval P120006/S030 · decided 2018-05-08
Approval details
- PMA number
- P120006
- Supplement
- S030
- 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
- 2018-02-09
- Decision date
- 2018-05-08
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for the modification of the inner handle of the Ovation iX aortic body delivery 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.