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: FORTIFY VR/DR
• Classification Name: pulse generator, permanent, implantable
• Generic Name: transtelephonic follow-up/monitoring system
• Applicant: ST. JUDE MEDICAL
• PMA Number: P910023
• Supplement Number: S239
• Date Received: 07/27/2010
• Decision Date: 09/23/2010
• Product Code: NVZ [ Registered Establishments with NVZ ]
• Advisory Committee: Cardiovascular
• Supplement Type: real-time process
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for changes to the labeling to include longevity information based on additional bench testing.