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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.
 
DeviceIlivia Neo 7 VR-T DX DF-1 ProMRI, Ilivia Neo 7 VR-T DF-1 ProMRI, Intica Neo 7 VR-T DX DF-1 ProMRI, Intica Neo 7 VR-T DF-
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS152
Date Received09/18/2026
Decision Date10/13/2026
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  
a change to the rework process for the manufacturing of the housing for pulse generators and ICDS
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