Approval for a change in the material of the remede ipg from hysol to epo-tek 301 as the epoxy resin encapsulation material.
| 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 | 2018-05-01 |
| Decision Date | 2018-09-12 |
| PMA | P160039 |
| Supplement | S003 |
| Product Code | PSR |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Anesthesiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | RESPICARDIA 12400 Whitewater Drive suite 150 minnetonka, MN 55343 |
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