AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM
FDA premarket approval P110032/S001 · decided 2013-11-01
Approval details
- PMA number
- P110032
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Lombard Medical Limited
- Date received
- 2013-03-15
- Decision date
- 2013-11-01
- Days to decision
- 231 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Didcot
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