EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)
FDA premarket approval P110023 · decided 2012-03-07
Approval details
- PMA number
- P110023
- Trade name
- EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2011-06-13
- Decision date
- 2012-03-07
- Days to decision
- 268 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR THE EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM. THIS DEVICE IS INTENDED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF SYMPTOMATIC DE NOVO OR RESTENOTIC LESIONS UP TO 180MM IN LENGTH IN THE NATIVE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.5 -7.5MM.
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510(k) clearances by this applicant
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|---|---|---|
| Heli-FX EndoAnchor System (K182957) | Medtronic Vascular, Inc. | 2018-11-21 |
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| SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System (K170191) | Medtronic Vascular, Inc. | 2017-06-16 |
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| HawkOne Directional Atherectomy System (K161361) | Medtronic Vascular, Inc. | 2016-10-14 |