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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 NameBIOTRONIK GEMNOS 04, 04A, AND TC 04
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable, unipolar, multiprogrammable pulse g
ApplicantBIOTRONIK, GMBH & CO.
PMA NumberP820076
Supplement NumberS020
Date Received05/04/1995
Decision Date12/22/1995
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the change in the burn-in processing of the wilson greatbatch batteries which are used in your listed pacemakers. This process change is a reduction of the battery burn-in time from 35 days to 4 days.
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