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: CELSIUS CATHETERS
• Classification Name: cardiac ablation percutaneous catheter
• Generic Name: radiofrequency ablation catheter, electrode recording catheter
• Applicant: BIOSENSE WEBSTER, INC.
• PMA Number: P950005
• Supplement Number: S040
• Date Received: 09/25/2012
• Decision Date: 10/24/2012
• Product Code: LPB [ Registered Establishments with LPB ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Addition of an alternate supplier for the extruding and braiding process.