Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: CHILLI COOLED ABLATION CATHETER
• Classification Name: cardiac ablation percutaneous catheter
• Generic Name: rf ablation system
• Applicant: BOSTON SCIENTIFIC CORP.
• PMA Number: P980003
• Supplement Number: S021
• Date Received: 04/23/2008
• Decision Date: 09/19/2008
• Product Code: LPB [ Registered Establishments with LPB ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Supplement Reason: labeling for post approval study
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for labeling changes resulting from completion of the condition of approval study.