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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 NamePERMANENT PACEMAKER ELECTRODE
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pacemaker pulse generator, pacemaker programmer
ApplicantBIOTRONIK, INC.
PMA NumberP820076
Supplement NumberS023
Date Received11/20/2002
Decision Date12/20/2002
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Reduction in the incubation time of the biological indicators utilized during the standard sterilization process, from 7 days to 3 days.
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