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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.
 
DevicePlexa S 60, Plexa ProMRI S 60, Plexa ProMRI S 65, Plexa ProMRI S 75, Plexa SD 60/16, Plexa ProMRI SD 60/16, Plexa ProMRI
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS120
Date Received03/07/2023
Decision Date04/04/2023
Product Code LWS 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Introduction of an automatic optical inspection for the blister packaging of ICD lead families and updates to visual inspection criteria.
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