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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 NumberS006
Date Received01/19/2021
Decision Date07/28/2021
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 reducing the IPG size, increasing the IPG battery longevity, reducing the number of set screw connections between the lead terminal and IPG header, and improving features within the Remede Programer software application and the remede Reports application.
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