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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 IPG
Generic NameImplanted phrenic nerve stimulator for central sleep apnea
ApplicantRespicardia
12400 Whitewater Dr.
Suite 150
Minnetonka, MN 55343
PMA NumberP160039
Supplement NumberS009
Date Received05/01/2023
Decision Date11/09/2023
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 introducing ease of use features to aid clinicians when during follow up visits and extending the shelf life the GEN 1.5 Model 1100/1600 IPGs packaging from 2 years to 4 years.
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