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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.
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
4100 hamline avenue north
st. paul, MN 55112
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/material
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.