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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.
 
DeviceOPTIMIZER Smart, OPTIMIZER Smart Mini, OPTIMIZER Lite
Generic NameImplantable pulse generator
ApplicantImpulse Dynamics (Usa), Inc.
50 Lake Center Executive Pkwy.
401 Rte. 73 N, Bldg. 50 Suite 100
Marlton, NJ 08053
PMA NumberP180036
Supplement NumberS033
Date Received08/12/2024
Decision Date03/27/2025
Product Code QFV 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
additional of a raw material supplier for epoxy resin used in the OPTIMIZER IPG devices.
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