PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEMS
FDA premarket approval P060001/S006 · decided 2008-10-08
Approval details
- PMA number
- P060001
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEMS
- Generic name
- Stent, carotid
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2008-05-16
- Decision date
- 2008-10-08
- Days to decision
- 145 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY.
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