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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.
 
DeviceBIOTRONIK SOFTWARE MODULE SWM 600 V.D05U01
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP820076
Supplement NumberS017
Date Received11/16/1994
Decision Date09/07/1995
Withdrawal Date08/05/2019
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE SWM 600 VERSION DO5U01 SOFTWARE MODULE FOR USE WITH THE MODEL PMS 600 PROGRAMMER
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