MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM
FDA premarket approval P110040 · decided 2013-09-19
Approval details
- PMA number
- P110040
- Trade name
- MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Medtronic Vascular
- Date received
- 2011-12-12
- Decision date
- 2013-09-19
- Days to decision
- 647 days
- Decision code
- APWD
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM. THIS DEVICE IS INDICATED TO IMPROVE LUMINAL DIAMETER IN SYMPTOMATIC PATIENTS WITH DE NOVO AND/OR RESTENOTIC LESIONS OR OCCLUSIONS OF THE SUPERFICIAL FEMORAL ARTERY (SFA) OR PROXIMAL POPLITEAL ARTERY (PPA) WITH REFERENCE DIAMETERS RANGING FROM 4 MM TO 7 MM AND LESION LENGTHS UP TO 140 MM.
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