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.
| Device | remede® System |
| Classification Name | Implanted Phrenic Nerve Stimulator For Central Sleep Apnea |
| Generic Name | Implanted Phrenic Nerve Stimulator For Central Sleep Apnea |
| Applicant | RESPICARDIA |
| Date Received | 2016-09-06 |
| Decision Date | 2017-10-06 |
| Notice Date | 2017-10-23 |
| PMA | P160039 |
| Supplement | S |
| Product Code | PSR |
| Docket Number | 17M-6223 |
| Advisory Committee | Anesthesiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | RESPICARDIA 12400 Whitewater Drive suite 150 minnetonka, MN 55343 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160039 | | Original Filing |
| S007 |
2021-08-06 |
Normal 180 Day Track |
| S006 |
2021-01-19 |
Normal 180 Day Track |
| S005 |
2019-08-20 |
Normal 180 Day Track |
| S004 |
2018-10-16 |
Normal 180 Day Track |
| S003 |
2018-05-01 |
Normal 180 Day Track |
| S002 |
2018-02-27 |
Normal 180 Day Track |
| S001 |
2017-10-30 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices