COMPLETE SE VASCULAR STENT SYSTEM
FDA premarket approval P090006 · decided 2010-03-17
Approval details
- PMA number
- P090006
- Trade name
- COMPLETE SE VASCULAR STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Medtronic Vascular
- Date received
- 2009-04-15
- Decision date
- 2010-03-17
- Days to decision
- 336 days
- Decision code
- APWD
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE COMPLETE SE VASCULAR STENT SYSTEM (20-100MM LENGTHS). THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH ILIAC STENOSIS IN PREVIOUSLY UNSTENTED LESIONS WITH VESSEL REFERENCE DIAMETERS BETWEEN 4.5MM AND 9.5MM AND LESION LENGTHS UP TO 90MM.
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