Enroute Transcarotid Stent System
FDA premarket approval P140026/S006 · decided 2017-04-13
Approval details
- PMA number
- P140026
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- Enroute Transcarotid Stent System
- Generic name
- Stent, carotid
- Applicant
- Boston Scientific Corporation
- Date received
- 2017-02-14
- Decision date
- 2017-04-13
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marborough, MA
- Statement
- Approval for changes to the protocol for the post-approval study (PAS) protocol.
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