ENROUTE® Transcarotid Stent System
FDA premarket approval P140026/S030 · decided 2024-10-25
Approval details
- PMA number
- P140026
- Supplement
- S030
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENROUTE® Transcarotid Stent System
- Generic name
- Stent, carotid
- Applicant
- Boston Scientific Corporation
- Date received
- 2024-09-27
- Decision date
- 2024-10-25
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marborough, MA
- Statement
- the removal of an in-process inspection test for the packaging system
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