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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 NumberS001
Date Received10/30/2017
Decision Date12/21/2017
Product Code PSR 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the protocol for the post-approval study (PAS).
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