ENROUTE TRANSCAROTID STENT SYSTEM
FDA premarket approval P140026/S002 · decided 2016-07-19
Approval details
- PMA number
- P140026
- Supplement
- S002
- 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
- 2016-03-07
- Decision date
- 2016-07-19
- Days to decision
- 134 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marborough, MA
- Statement
- Approval of the following changes to the post-approval study for the device: editorial, protocol, exclusion changes, as well as verbage changes.
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