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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 Defibrillator Electrodes
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS099
Date Received02/25/2020
Decision Date05/22/2020
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for additional MRI system configurations to include Plexa (ProMRI) S 60, Plexa (ProMRI) SD 60/16, Plexa (ProMRI) DF-1 S 60 and Plexa (ProMRI) DF-1 SD 60/16.
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