|
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 | S004 |
Date Received | 10/16/2018 |
Decision Date | 01/30/2019 |
Product Code |
PSR |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change in packaging and sterilization process to the remed? System IPG. |