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: SAFIRE ABLATION SYSTEM
• Classification Name: cardiac ablation percutaneous catheter
• Generic Name: cardiac ablation catheter
• Applicant: ST. JUDE MEDICAL
• PMA Number: P960016
• Supplement Number: S039
• Date Received: 07/23/2012
• Decision Date: 09/10/2012
• Product Code: LPB [ Registered Establishments with LPB ]
• Advisory Committee: Cardiovascular
• Supplement Type: real-time process
• Supplement Reason: design change - minor
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for minor design modifications to the pinion gear component.