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: MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER
• Classification Name: generator, pulse, pacemaker, external programmable
• Generic Name: pacemaker
• Regulation Number: 870.1750
• Applicant: PACE MEDICAL
• PMA Number: P920032
• Supplement Number: S004
• Date Received: 01/30/1998
• Decision Date: 02/27/1998
• Product Code: JOQ [ Registered Establishments with JOQ ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Supplement Reason: design change - minor
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for a modified switch guard design.