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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
Deviceremede® System
Generic Nameimplanted phrenic nerve stimulator for central sleep apnea
ApplicantRESPICARDIA
12400 whitewater drive
suite 150
minnetonka, MN 55343
PMA NumberP160039
Date Received09/06/2016
Decision Date10/06/2017
Product Code PSR 
Docket Number 17M-6223
Notice Date 10/23/2017
Advisory Committee Anesthesiology
Clinical TrialsNCT01816776
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the remed® System. This device is an implantable phrenic nerve stimulator indicated for the treatment of moderate to severe central sleep apnea (CSA) in adult patients.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 
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