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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.
 
DeviceMODEL PMS 1000 PROGRAMMING AND MONITORING SYSTEM WITH SOFTWARE MODULE SWM 1000, VERSION C01.C02.U
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP820076
Supplement NumberS019
Date Received05/02/1995
Decision Date01/24/1996
Withdrawal Date 08/05/2019
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MODEL PMS 1000 PROGRAMMING AND MONITORING SYSTEM WITH SOFTWARE MODULE SWM 1000, VERSION C01.C02.U
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