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 COOLED ABLATION SYSTEM
• Generic Name: Cardiac ablation percutaneous catheter
• Applicant: Boston Scientific Corp; 150 Baytech Dr.; San Jose, CA 95134
• PMA Number: P980003
• Supplement Number: S004
• Date Received: 12/26/2001
• Decision Date: 01/08/2002
• Withdrawal Date: 02/28/2024
• Product Code: LPB
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Express GMP Supplement
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR THE ADDITIONAL MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC CORPORATION, SAN JOSE, CALIFORNIA.