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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 PACING SYSYTEM
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator and programmer
Regulation Number870.3610
ApplicantSULZER INTERMEDICS, INC.
PMA NumberP910020
Supplement NumberS017
Date Received08/05/1996
Decision Date02/10/1997
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 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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