PMA P160039S007
- Device
- remede® System
- Applicant
- Respicardia
- PMA number
- P160039
- Supplement
- S007
- Product code
- PSR
- Decision date
- 2022-01-10
- Generic name
- Implanted phrenic nerve stimulator for central sleep apnea
- Approval order statement
- Approval of a change to the GEN 1.5 IPG firmware (FW) from version 1.13 to version 1.14.
Current openFDA PMA Record#
- Device
- remede® System
- Applicant
- Respicardia
- PMA number
- P160039
- Supplement
- S007
- Product code
- PSR
- Generic name
- Implanted phrenic nerve stimulator for central sleep apnea
- Decision date
- 2022-01-10
- Decision code
- APPR
- Date received
- 2021-08-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval of a change to the GEN 1.5 IPG firmware (FW) from version 1.13 to version 1.14.