Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Chilli II Cooled Catheter, Sterile Cables, Tubing Kit
• Generic Name: Cardiac ablation percutaneous catheter
• Applicant: Boston Scientific Corp; 150 Baytech Dr.; San Jose, CA 95134
• PMA Number: P980003
• Supplement Number: S093
• Date Received: 01/28/2022
• Decision Date: 02/25/2022
• Withdrawal Date: 02/28/2024
• Product Code: LPB
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Introduction of parametric release for the BSC2000-2 Ethylene Oxide Sterilization Cycle at the BSC Coventry, RI Facility.