PMA P160039S008
- Device
- remede® System
- Applicant
- Respicardia
- PMA number
- P160039
- Supplement
- S008
- Product code
- PSR
- Decision date
- 2023-03-28
- Classification
- Anesthesiology
- Generic name
- Implanted phrenic nerve stimulator for central sleep apnea
- Approval order statement
- Approval for adding MR Conditional labeling for 1.5T and 3T MRI scans to the implantable components of remede System.
Current openFDA PMA Record#
- Device
- remede® System
- Applicant
- Respicardia
- PMA number
- P160039
- Supplement
- S008
- Product code
- PSR
- Generic name
- Implanted phrenic nerve stimulator for central sleep apnea
- Decision date
- 2023-03-28
- Decision code
- APPR
- Date received
- 2022-03-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for adding MR Conditional labeling for 1.5T and 3T MRI scans to the implantable components of remede System.