EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM
FDA premarket approval P110023/S014 · decided 2015-04-02
Approval details
- PMA number
- P110023
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2015-03-15
- Decision date
- 2015-04-02
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- REPLACE THE CURRENT THERMAL BONDING MACHINE USED IN THE DISTAL BONDING PROCESS OF THE CATHETER.
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