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 II COOLED ABLATION CATHETER & CABLE
• Classification Name: cardiac ablation percutaneous catheter
• Generic Name: rf ablation system
• Applicant: BOSTON SCIENTIFIC
• PMA Number: P980003
• Supplement Number: S024
• Date Received: 10/12/2010
• Decision Date: 03/31/2011
• Product Code: LPB [ Registered Establishments with LPB ]
• Advisory Committee: Cardiovascular
• Supplement Type: 135 review track for 30-day notice
• Supplement Reason: process change: sterilization
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for a change to the sterilization equipment.