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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 HF -T QP, Ilivia Neo 7 HF -T, Intica Neo 7 HF -T QP, Intica Neo 7 HF -T, Intica Neo 5 HF -T QP, Intica Neo
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP000009
Supplement NumberS113
Date Received07/11/2024
Decision Date09/03/2024
Product Code MRM 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a battery separator material change for GB 2992 and GB 3493 batteries used in Acticor, Ilivia Neo, and Ilivia ICD and CRT-D device families
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