PMA P160039S002
- Device
- Remede® System
- Applicant
- Respicardia
- PMA number
- P160039
- Supplement
- S002
- Product code
- PSR
- Decision date
- 2018-11-02
- Classification
- Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
- Generic name
- Implanted phrenic nerve stimulator for central sleep apnea
- Approval order statement
- Approval for an update to the tablet hardware and software of the Model 1002A Remede System Programmer.
Current openFDA PMA Record#
- Device
- Remede® System
- Applicant
- Respicardia
- PMA number
- P160039
- Supplement
- S002
- Product code
- PSR
- Generic name
- Implanted phrenic nerve stimulator for central sleep apnea
- Decision date
- 2018-11-02
- Decision code
- APPR
- Date received
- 2018-02-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an update to the tablet hardware and software of the Model 1002A Remede System Programmer.