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: THERAPY CARDIAC ABLATION CATHETER
• Classification Name: cardiac ablation percutaneous catheter
• Generic Name: cardiac ablation system
• Applicant: ST. JUDE MEDICAL
• PMA Number: P040014
• Supplement Number: S012
• Date Received: 12/14/2009
• Decision Date: 01/12/2010
• 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 a step prior to bonding the tip.