|
Device | remede System IPG |
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 | S009 |
Date Received | 05/01/2023 |
Decision Date | 11/09/2023 |
Product Code |
PSR |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval for introducing ease of use features to aid clinicians when during follow up visits and extending the shelf life the GEN 1.5 Model 1100/1600 IPGs packaging from 2 years to 4 years. |