Aorfix AAA Flexible Stent Graft System with Aorflex Delivery Device
FDA premarket approval P110032/S013 · decided 2017-09-20
Approval details
- PMA number
- P110032
- Supplement
- S013
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- Aorfix AAA Flexible Stent Graft System with Aorflex Delivery Device
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Lombard Medical Limited
- Date received
- 2017-07-24
- Decision date
- 2017-09-20
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Didcot
- Statement
- Approval to the post-approval study (PAS) protocol.
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