PROTEGE GPS & RX CAROTID STENT SYSTEMS
FDA premarket approval P060001/S002 · decided 2007-07-17
Approval details
- PMA number
- P060001
- Supplement
- S002
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROTEGE GPS & RX CAROTID STENT SYSTEMS
- Generic name
- Stent, carotid
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2007-01-31
- Decision date
- 2007-07-17
- Days to decision
- 167 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR A CHANGE TO THE MANUFACTURING PROCESS TO INCLUDE ALTERNATE PROCESS CHALLENGE DEVICES (PCD).
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