Premarket Approval (PMA)

Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.

• Trade Name: KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR
• Classification Name: implantable pacemaker pulse-generator
• Generic Name: pulse generator, sensing lead and programmer
• Regulation Number: 870.3610
• Applicant: COOK PACEMAKER CORP.
• PMA Number: P870054
• Date Received: 09/08/1987
• Decision Date: 04/29/1988
• Withdrawal Date: 12/01/2004
• Product Code: DXY [ Registered Establishments with DXY ]
• Docket Number: 88M-0187
• Notice Date: 06/09/1988
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Supplements: S001 S002 S003 S004 S005 S006 ; S009 S010 S011 S014