EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)
FDA premarket approval P110023/S056 · decided 2025-08-05
Approval details
- PMA number
- P110023
- Supplement
- S056
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2025-01-30
- Decision date
- 2025-08-05
- Days to decision
- 187 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for a line extension for the SFA/PPA indication, which includes the addition of a 5.0mm stent diameter and reduction in minimum rated vessel diameter to 4.0 mm
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Heli-FX EndoAnchor System (K182957) | Medtronic Vascular, Inc. | 2018-11-21 |
| Sentrant Introducer Sheath with Hydrophilic Coating (K171866) | Medtronic Vascular, Inc. | 2017-12-20 |
| SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System (K170191) | Medtronic Vascular, Inc. | 2017-06-16 |
| Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette (K171427) | Medtronic Vascular, Inc. | 2017-06-13 |
| HawkOne Directional Atherectomy System (K161361) | Medtronic Vascular, Inc. | 2016-10-14 |