AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM
FDA premarket approval P110032/S006 · decided 2013-11-21
Approval details
- PMA number
- P110032
- Supplement
- S006
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Lombard Medical Limited
- Date received
- 2013-10-22
- Decision date
- 2013-11-21
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Didcot
- Statement
- APPROVAL FOR REVISED INSTRUCTIONS FOR USE (IFU) TO ADD WARNINGS AND PRECAUTIONS BASED ON DATA FROM ONGOING FOLLOW-UP OF SUBJECTS IN THE IDE STUDY.
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