EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM
FDA premarket approval P110023/S010 · decided 2014-09-03
Approval details
- PMA number
- P110023
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2014-07-10
- Decision date
- 2014-09-03
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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