ENDURANT II STENT GRAFT SYSTEM
FDA premarket approval P100021/S011 · decided 2012-04-27
Approval details
- PMA number
- P100021
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDURANT II STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2011-11-02
- Decision date
- 2012-04-27
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR A MODIFIED VERSION OF THE ENDURANT STENT GRAFT SYSTEM. THE ENDURANT II STENT GRAFT SYSTEM IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTO-ILIAC ANEURYSMS HAVING ADEQUATE ILIAC/FEMORAL ACCESS THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES AND/OR ACCESSORIES; PROXIMAL NECK LENGTH OF => 10 MM: INFRARENAL NECK ANGULATION OF =< 60°; DISTAL FIXATION LENGTH OF => 15 MM; AORTIC NECK DIAMETERS WITH A RANGE OF 19-32 MM; ILIAC DIAMETERS WITH A R
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.