PROTEGE GPS STENT SYSTEM
FDA premarket approval P060001/S024 · decided 2015-12-14
Approval details
- PMA number
- P060001
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROTEGE GPS STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2015-11-23
- Decision date
- 2015-12-14
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- A CHANGE TO YOUR MANUFACTURING EQUIPMENT FOR THE PROTEGE GPS STENT SYSTEM.
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