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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 SOFTWARE MODULE SWM 600 V.D05U01
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable, unipolar, multiprogrammable pulse g
ApplicantBIOTRONIK, GMBH & CO.
PMA NumberP820076
Supplement NumberS017
Date Received11/16/1994
Decision Date09/07/1995
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the swm 600 version do5u01 software module for use with the model pms 600 programmer.
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