MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM
FDA premarket approval P100021 · decided 2010-12-16
Approval details
- PMA number
- P100021
- Trade name
- MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2010-06-04
- Decision date
- 2010-12-16
- Days to decision
- 195 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE ENDURANT STENT GRAFT SYSTEM. THE DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTO-ILIAC ANEURYSMS IN PATIENTS WITH THE FOLLOWING CHARACTERISTICS: 1) ADEQUATE ILIAC OR FEMORAL ACCESS THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, OR ACCESSORIES; 2) PROXIMAL NECK LENGTH OF >= 10MM; 3) INFRARENAL NECK ANGULATION <= 60 DEGREES; 4) DISTAL FIXATION LENGTH OF >= 15 MM; 5) AORTIC NECK DIAMETERS WITH A RANGE OF 19 TO 32 MM; 6) ILIAC
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.