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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 NameMOMENTUM PACERS
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator and programmer
Regulation Number870.3610
ApplicantSULZER INTERMEDICS, INC.
PMA NumberP910020
Supplement NumberS019
Date Received06/23/1997
Decision Date07/29/1997
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the momentum pulse generator models 294-23, 294-23z, and 293-23 with rx5000 programmer model 522-12 with marathon application software version 3. 00.
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