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: AV PLUS DX MODEL 1368 LEAD
• Classification Name: programmer, pacemaker
• Generic Name: cardiac pacemaker
• Regulation Number: 870.3700
• Applicant: ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
• PMA Number: P880086
• Supplement Number: S076
• Date Received: 08/01/2000
• Decision Date: 08/25/2000
• Product Code: KRG [ Registered Establishments with KRG ]
• Advisory Committee: Cardiovascular
• Supplement Type: real-time process
• Supplement Reason: design change - minor
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for an additional lead length of 65 cm.