AORFIX FLEXIBLE STENT GRAFT SYSTEM
FDA premarket approval P110032 · decided 2013-02-14
Approval details
- PMA number
- P110032
- Trade name
- AORFIX FLEXIBLE STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Lombard Medical Limited
- Date received
- 2011-08-15
- Decision date
- 2013-02-14
- Days to decision
- 549 days
- Decision code
- APWD
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Didcot
- Statement
- APPROVAL FOR THE AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM. THIS DEVICE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC AND AORTO-ILIAC ANEURYSMS HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULARREPAIR, INCLUDING:1) ADEQUATE ILIAC OR FEMORAL ACCESS THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, IMPLANTS, AND ACCESSORIES; 2) AORTIC NECK LANDING ZONE DIAMETERS WITH A RANGE OF 19MM TO 29MM; 3) NON ANEURYSMAL PROXIMAL NECK CENTER-LINE LENGTH OF >= L5MM; 4) LNFRARENAL AORTIC NEC
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