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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 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 NameMARATHON FAMILY OF PULSE GENERATORS AND THE MODEL 531-66
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator and programmer
Regulation Number870.3610
ApplicantINTERMEDICS, INC.
PMA NumberP910020
Supplement NumberS013
Date Received12/14/1995
Decision Date05/03/1996
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
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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