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: Chill II
• Generic Name: Cardiac ablation percutaneous catheter
• Applicant: Boston Scientific Corp; 150 Baytech Dr.; San Jose, CA 95134
• PMA Number: P980003
• Supplement Number: S079
• Date Received: 08/30/2017
• Decision Date: 09/26/2017
• 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  
Add an alternate vendor for Tyvek Pouch utilized with the BSC Ablation Catheters.