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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
Classification Nameimplanted phrenic nerve stimulator for central sleep apnea
Generic Nameimplanted phrenic nerve stimulator for central sleep apnea
Applicant
RESPICARDIA
12400 whitewater drive
suite 150
minnetonka, MN 55343
PMA NumberP160039
Date Received09/06/2016
Decision Date10/06/2017
Product Code
PSR[ Registered Establishments with PSR ]
Docket Number 17M-6223
Notice Date 10/23/2017
Advisory Committee Anesthesiology
Clinical Trials NCT01816776
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 
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