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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 NameSOFTWARE RELEASE NUMBER 2.4 4.31
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable, unipolar, multiprogrammable pulse g
ApplicantBIOTRONIK SALES, INC.
PMA NumberP820076
Supplement NumberS009
Date Received03/12/1990
Decision Date06/13/1990
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
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