PMA P980003S094
- Device
- Chilli Cooled RF Ablation System
- Applicant
- Boston Scientific Corp
- PMA number
- P980003
- Supplement
- S094
- Product code
- LPB
- Decision date
- 2022-11-15
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Change to a sterilization Chamber at the Boston Scientific Corporation (BSC) Coventry Rhode Island facility.
Current openFDA PMA Record#
- Device
- Chilli Cooled RF Ablation System
- Applicant
- Boston Scientific Corp
- PMA number
- P980003
- Supplement
- S094
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2022-11-15
- Decision code
- OK30
- Date received
- 2022-10-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to a sterilization Chamber at the Boston Scientific Corporation (BSC) Coventry Rhode Island facility.