PMA P160039S004
- Device
- remede® System
- Applicant
- Respicardia
- PMA number
- P160039
- Supplement
- S004
- Product code
- PSR
- Decision date
- 2019-01-30
- Classification
- Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
- Generic name
- Implanted phrenic nerve stimulator for central sleep apnea
- Approval order statement
- Approval for a change in packaging and sterilization process to the remed? System IPG.
Current openFDA PMA Record#
- Device
- remede® System
- Applicant
- Respicardia
- PMA number
- P160039
- Supplement
- S004
- Product code
- PSR
- Generic name
- Implanted phrenic nerve stimulator for central sleep apnea
- Decision date
- 2019-01-30
- Decision code
- APPR
- Date received
- 2018-10-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change in packaging and sterilization process to the remed? System IPG.