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: CADENCE
• Classification Name: pulse generator, permanent, implantable
• Generic Name: transtelephonic follow-up/monitoring system
• Applicant: ST. JUDE MEDICAL
• PMA Number: P910023
• Supplement Number: S187
• Date Received: 08/11/2008
• Decision Date: 09/10/2008
• 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 
Change in the rework process and the addition of a new piece of equipment.