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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 FAMILY OF PULSE GENERATORS AND THE MODEL 531-66
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910020
Supplement NumberS013
Date Received12/14/1995
Decision Date05/03/1996
Withdrawal Date07/20/2012
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MARATHON FAMILY OF PULSE GENERATORS AND THE MODEL 531-66 GRAPHICS PROGRAM MODULE. THE MARATHON FAMILY OF PULSE GENERATORS CONSISTS OF THE FOLLOWING MODELS: - MARATHON DR MODELS 294-09, 293-09, 294-09R, 294-10; MARATHON SR MODELS 292-09, 291-09, 292-09R, 292-10, 292-09X; COSMOS 3 MODELS 283-09, 284-09, 284-09R
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