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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 NameMEDTRONIC MODEL 5388 EXTERNAL PULSE GENERATOR (EPG)
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual chamber, implantable pulse generator
Applicant MEDTRONIC INC.
PMA NumberP820003
Supplement NumberS099
Date Received10/06/2010
Decision Date12/16/2010
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the replacement of the socket with soldering of the eprom on the main board for the model 5388 external pulse generator (epg).
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