Ovation iX Abdominal Stent Graft System
FDA premarket approval P120006/S036 · decided 2020-07-09
Approval details
- PMA number
- P120006
- Supplement
- S036
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Ovation iX Abdominal Stent Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2020-06-09
- Decision date
- 2020-07-09
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for updating the IFU with the following language:Polymer leaks are a unique potential risk of the Ovation device platform that have been reported post-market. The complications of polymer leakage in to the vasculature have ranged from transient hypotension to severe life-threatening anaphylactoid reactions, tissue necrosis and death. When polymer leaks occur, underfilling of the Ovation iX sealing rings have led to intraoperative Type Ia endoleaks that have required additional therapy.
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