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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 Pkwy.
401 Rte. 73 N, Bldg. 50 Suite 100
Marlton, NJ 08053
PMA NumberP180036
Supplement NumberS035
Date Received09/25/2024
Decision Date10/23/2024
Product Code QFV 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P180036.
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