EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)
FDA premarket approval P110023/S022 · decided 2016-11-25
Approval details
- PMA number
- P110023
- Supplement
- S022
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2016-11-02
- Decision date
- 2016-11-25
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Updates to process parameters.
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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 |