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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.
30 ramland road south, suite 204
orangeburg, NY 10962
PMA NumberP180036
Supplement NumberS005
Date Received02/26/2020
Decision Date09/02/2020
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 ProductNo
Approval Order Statement  
Approval for the removal of the contraindication Patients with permanent or long-standing persistent atrial fibrillation or flutter.