|
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 |
Supplement Number | S008 |
Date Received | 03/01/2022 |
Decision Date | 03/28/2023 |
Product Code |
PSR |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for adding MR Conditional labeling for 1.5T and 3T MRI scans to the implantable components of remede System. |