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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 System
Generic NameImplantable pulse generator
ApplicantImpulse Dynamics (USA), Inc.
50 Lake Center Executive Parkway
401 Route 73N, Bldg. 50 ste 100
Marlton, NJ 08053
PMA NumberP180036
Supplement NumberS026
Date Received12/22/2023
Decision Date01/03/2024
Product Code QFV 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
to add a refurbishment process for the Mini Charger by replacing the battery pack
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