PMA P160039S011

Device: remede System
Applicant: Respicardia
PMA number: P160039
Supplement: S011
Product code: PSR
Decision date: 2025-05-07
Classification: Anesthesiology
Generic name: Implanted phrenic nerve stimulator for central sleep apnea
Approval order statement: revised MR Conditional labeling of the remed?® System to remove the requirement to program the IPG to OFF mode prior to MRI scanning as the device automatically enters and remains in the Therapy Disabled (Magnet Mode) state during MRI exposure

Current openFDA PMA Record#

Device: remede System
Applicant: Respicardia
PMA number: P160039
Supplement: S011
Product code: PSR
Generic name: Implanted phrenic nerve stimulator for central sleep apnea
Decision date: 2025-05-07
Decision code: APPR
Date received: 2025-02-06
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: revised MR Conditional labeling of the remed?® System to remove the requirement to program the IPG to OFF mode prior to MRI scanning as the device automatically enters and remains in the Therapy Disabled (Magnet Mode) state during MRI exposure