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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.
 
DevicePacemaker/ICD/CRT non-implanted components
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP050023
Supplement NumberS171
Date Received12/19/2022
Decision Date06/28/2023
Product Code MRM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Amvia and Solvia family of pulse generators and cardiac resynchronization therapy pacekaer devices, as well as for updated programmer software versions PSW 2204.U and NEO 2204.U, updated Home Monitoring Service Center software version 3.55.0, and updates to the CardioMessenger Smart 4G firmware.
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