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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 Mini Implantable Pulse Generation (IPG)
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 NumberS020
Date Received05/01/2023
Decision Date10/23/2023
Product Code QFV 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for expanded MR Conditional labeling for the OPTIMIZER Smart Mini when combined with certain market approved pacing leads.
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