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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 NumberS005
Date Received08/20/2019
Decision Date12/23/2019
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 for software changes to the Model 7001 Remede Reports Application and the addition of Respistim LQ/LQS stimulation lead models to the family of respistim L (left) leads.
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