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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.
 
DeviceDrug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS249
Date Received03/30/2023
Decision Date06/28/2023
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the MR Conditional labeling of additional system configurations with partially capped Pamira or Plexa DF4 S DX ICD leads when used under specific scan conditions.
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