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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMARATHON PACING SYSYTEM
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP910020
Supplement NumberS017
Date Received08/05/1996
Decision Date02/10/1997
Withdrawal Date 07/20/2012
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE MARATHON DR AND SR PULSE GENERATORS, GRAPHICS PROGRAM MODULE MODEL 570-01, AND TO THE RELEASE 2.00 SOFTWARE FOR USE WITH THE RX5000 GRAPHICS PROGRAMMER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES MARATHON Z PULSE GENERATOR MAODELS 294-09Z AND 292-09Z, MOMENTUM DR PULSE GENERATOR MODELS 294-23, 294-23Z, AND 292-23, GRAPHICS PROGRAM MODULE MODEL 570-01, AND RELEASE 2.02 SOFTWARE WITH USE WITH RX5000 GRAPHICS PROGRAMMER, AND IS INDICATED FOR LONG TERM CARDIAC PACING
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