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: ICDS
• Classification Name: pulse generator, permanent, implantable
• Generic Name: transtelephonic follow-up/monitoring system
• Applicant: ST. JUDE MEDICAL
• PMA Number: P910023
• Supplement Number: S250
• Date Received: 09/20/2010
• Decision Date: 10/19/2010
• 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 
Extension of primer dwell time from 24 to 72 hours.