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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.
 
DevicePamira ICD Leads
Generic NamePermanent defibrillator electrodes
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS113
Date Received05/19/2022
Decision Date01/20/2023
Product Code NVY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for design changes to the Plexa lead family, resulting in the Pamira lead family.
Post-Approval StudyShow Report Schedule and Study Progress
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