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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 NumberS020
Date Received01/08/1998
Decision Date01/30/1998
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 edgeband design on the marathon sr model 292-09, relay model 293-03, marathon dr model 293-09, marathon dr model 294-09, and mementum dr model 294-23. The devices, as modified, will be marketed under the trade name edgeband pacemakers, with the following models: marathon sr model 292-09e, relay model 293-03e, marathone dr model 293-09e, marathon dr model 294-09e, and momentum dr model 294-23e. The supplement also requested approval for the use of an alternate packaging of polyethylene terephthalate glycol (petg) for all edgeband and all side-lock(tm) pulse generator models.
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