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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.
 
Deviceremede® System
Generic NameImplanted phrenic nerve stimulator for central sleep apnea
ApplicantRESPICARDIA
12400 WHITEWATER DRIVE
SUITE 150
MINNETONKA, MN 55343
PMA NumberP160039
Supplement NumberS005
Date Received08/20/2019
Decision Date12/23/2019
Product Code PSR 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for software changes to the Model 7001 Remede Reports Application and the addition of Respistim LQ/LQS stimulation lead models to the family of respistim L (left) leads.
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