EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM
FDA premarket approval P110023/S006 · decided 2014-06-22
Approval details
- PMA number
- P110023
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2014-02-03
- Decision date
- 2014-06-22
- Days to decision
- 139 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR UPDATED LABELING THAT INCLUDES 3-YEAR CLINICAL OUTCOMES.
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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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| HawkOne Directional Atherectomy System (K161361) | Medtronic Vascular, Inc. | 2016-10-14 |