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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 NumberS004
Date Received10/16/2018
Decision Date01/30/2019
Product Code PSR 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change in packaging and sterilization process to the remed? System IPG.
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