Premarket Approval (PMA)

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.

• Device: remede® System
• Generic Name: Implanted phrenic nerve stimulator for central sleep apnea
• Applicant: Respicardia; 12400 Whitewater Dr.; Suite 150; Minnetonka, MN 55343
• PMA Number: P160039
• Supplement Number: S001
• Date Received: 10/30/2017
• Decision Date: 12/21/2017
• Product Code: PSR
• Advisory Committee: Anesthesiology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the protocol for the post-approval study (PAS).