PROTEGE GPS CAROTID STENT SYSTEM, PROTEGE GPS SELF-EXPANDING PERIPHERAL STENT SYSTEM
FDA premarket approval P060001/S023 · decided 2015-04-02
Approval details
- PMA number
- P060001
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROTEGE GPS CAROTID STENT SYSTEM, PROTEGE GPS SELF-EXPANDING PERIPHERAL STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2015-03-16
- Decision date
- 2015-04-02
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- NIO
- 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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