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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 Dr.
Suite 150
Minnetonka, MN 55343
PMA NumberP160039
Supplement NumberS007
Date Received08/06/2021
Decision Date01/10/2022
Product Code PSR 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of a change to the GEN 1.5 IPG firmware (FW) from version 1.13 to version 1.14.
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