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 CARDIAC ABLATION SYSTEM
• Classification Name: cardiac ablation percutaneous catheter
• Generic Name: cardiac ablation catheter
• Applicant: ST. JUDE MEDICAL
• PMA Number: P960016
• Supplement Number: S026
• Date Received: 10/29/2009
• Decision Date: 11/25/2009
• 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 
Change in manual brazing process.