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: TEMPO FAMILY OF PULSE GENERATORS
• Classification Name: implantable pacemaker pulse-generator
• Generic Name: cardiac pacemakers
• Regulation Number: 870.3610
• Applicant: PACESETTER, INC.
• PMA Number: P900070
• Supplement Number: S024
• Date Received: 10/06/1998
• Decision Date: 10/29/1998
• Product Code: DXY [ Registered Establishments with DXY ]
• Advisory Committee: Cardiovascular
• Supplement Type: real-time process
• Supplement Reason: labeling change - shelf-life
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for an extension of product shelf life from 12 months to 18 months.