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: PULSE GENERATOR
• Classification Name: programmer, pacemaker
• Generic Name: tiered therapy implantable defibrillator
• Regulation Number: 870.3700
• Applicant: ST. JUDE MEDICAL, INC.
• PMA Number: P880086
• Supplement Number: S104
• Date Received: 06/20/2005
• Decision Date: 07/08/2005
• Product Code: KRG [ Registered Establishments with KRG ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Removal of an automatic washing machine step in the current washing process of pacemakers.