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: VENTAK PRIZM MODELS 1850 AND 1851
• Classification Name: programmer, pacemaker
• Generic Name: cardiac resynchronization therapy defibrillator (crt-d) system
• Regulation Number: 870.3700
• Applicant: GUIDANT CORP.
• PMA Number: P960040
• Supplement Number: S038
• Date Received: 11/26/2003
• Decision Date: 12/24/2003
• Product Code: KRG [ Registered Establishments with KRG ]
• Advisory Committee: Cardiovascular
• Supplement Type: Special Supplement
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for labeling changes to update battery longevity information.