EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)
FDA premarket approval P110023/S021 · decided 2016-11-23
Approval details
- PMA number
- P110023
- Supplement
- S021
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2016-09-28
- Decision date
- 2016-11-23
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval to decrease the sample size in the post-approval study protocol.
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