PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM
FDA premarket approval P060001/S016 · decided 2012-01-18
Approval details
- PMA number
- P060001
- Supplement
- S016
- Supplement type
- 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
- 2011-12-19
- Decision date
- 2012-01-18
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- ADDITION OF A 7-PALLET STERILIZER VESSEL AT THE CONTRACT STERILIZER.
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