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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 (2-Lead configuration)
Generic Nameimplantable pulse generator
Impulse Dynamics (USA), Inc.
30 ramland road south, suite 204
orangeburg, NY 10962
PMA NumberP180036
Supplement NumberS006
Date Received06/22/2020
Decision Date12/30/2020
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 Product No
Approval Order Statement 
Approval for MR Conditional labeling for the OPTIMIZER Smart when combined with certain market approved pacing leads.