|
Device | remede® System |
Generic Name | Implanted phrenic nerve stimulator for central sleep apnea |
Applicant | RESPICARDIA 12400 WHITEWATER DRIVE SUITE 150 MINNETONKA, MN 55343 |
PMA Number | P160039 |
Date Received | 09/06/2016 |
Decision Date | 10/06/2017 |
Product Code |
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 Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 |