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: PARAGON/PHOENIX FAMILY PACEMAKERS
• Classification Name: pulse generator, permanent, implantable
• Generic Name: tiered therapy implantable defibrillator
• Applicant: ST. JUDE MEDICAL, INC.
• PMA Number: P830045
• Supplement Number: S102
• Date Received: 09/27/2006
• Decision Date: 10/25/2006
• Product Code: NVZ [ Registered Establishments with NVZ ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Automation of downloading merlin preference files through the final software update process.