Chilli II Cooled RF Ablation System
FDA premarket approval P980003/S095 · decided 2023-04-27
Approval details
- PMA number
- P980003
- Supplement
- S095
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Chilli II Cooled RF Ablation System
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 2023-03-30
- Decision date
- 2023-04-27
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- Use of parametric release and an alternate process challenge device for the BSC2019 ethylene oxide sterilization cycle at the Steris AST Costa Rica Facility.
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