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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 and Optimizer Smart Mini 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 NumberS008
Date Received06/24/2021
Decision Date10/06/2021
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
Approval Order Statement  
Approval for removing the Indications For Use requirement for patients to be in normal sinus rhythm.
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