PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM
FDA premarket approval P060001/S001 · decided 2007-07-17
Approval details
- PMA number
- P060001
- Supplement
- S001
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2007-01-29
- Decision date
- 2007-07-17
- Days to decision
- 169 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: 1) TO INCLUDE AN ALTERNATE THREE(3)-PALLET STERILIZATION CHAMBER AND 2) TO REDUCE THE FREQUENCY OF PYROGEN TESTING.
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