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: NAVISTAR THERMOCOOL CATHETER
• Classification Name: cardiac ablation percutaneous catheter
• Generic Name: drf(21 cfr 870.1220)
• Applicant: BIOSENSE WEBSTER, INC.
• PMA Number: P040036
• Supplement Number: S001
• Date Received: 10/19/2006
• Decision Date: 12/04/2006
• Product Code: LPB [ Registered Establishments with LPB ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: postapproval protocol or modification to a protocol
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval of the post-approval study.