PMA P140026S032
- Device
- ENROUTE® Transcarotid Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S032
- Product code
- NIM
- Decision date
- 2025-10-23
- Classification
- Cardiovascular
- Generic name
- Stent, carotid
- Approval order statement
- to transfer post-laser manufacturing processes of the stent component from Confluent in Fremont, California, to Confluent in Costa Rica
Current openFDA PMA Record#
- Device
- ENROUTE® Transcarotid Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S032
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2025-10-23
- Decision code
- OK30
- Date received
- 2025-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to transfer post-laser manufacturing processes of the stent component from Confluent in Fremont, California, to Confluent in Costa Rica