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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDIPLOS MODEL 03
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP820076
Supplement NumberS008
Date Received12/07/1989
Decision Date01/18/1990
Withdrawal Date 08/05/2019
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
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