PMA P160039S001
- Device
- remede® System
- Applicant
- Respicardia
- PMA number
- P160039
- Supplement
- S001
- Product code
- PSR
- Decision date
- 2017-12-21
- Classification
- Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
- Generic name
- Implanted phrenic nerve stimulator for central sleep apnea
- Approval order statement
- Approval of the protocol for the post-approval study (PAS).
Current openFDA PMA Record#
- Device
- remede® System
- Applicant
- Respicardia
- PMA number
- P160039
- Supplement
- S001
- Product code
- PSR
- Generic name
- Implanted phrenic nerve stimulator for central sleep apnea
- Decision date
- 2017-12-21
- Decision code
- APPR
- Date received
- 2017-10-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the post-approval study (PAS).