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: MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333
• Classification Name: implantable pacemaker pulse-generator
• Regulation Number: 870.3610
• Applicant: CARDIAC CONTROL SYSTEMS, INC.
• PMA Number: P890039
• Supplement Number: S014
• Date Received: 03/23/1995
• Decision Date: 05/16/1995
• Product Code: DXY [ Registered Establishments with DXY ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Supplement Reason: change design/components/specifications - other
• Expedited Review Granted?: No
• Combination Product: No