PMA P200018
- Device
- NeuRX Diaphragm Pacing System (DPS)
- Applicant
- Synapse Biomedical, Inc.
- PMA number
- P200018
- Product code
- OIR
- Decision date
- 2023-03-31
- Classification
- Anesthesiology
- Generic name
- diaphragmatic/phrenic nerve laparoscopically-implanted stimulator
- Approval order statement
- Approval for the NeuRx DPS® is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. For use only in patients 18 years of age or older.
Current openFDA PMA Record#
- Device
- NeuRX Diaphragm Pacing System (DPS)
- Applicant
- Synapse Biomedical, Inc.
- PMA number
- P200018
- Product code
- OIR
- Generic name
- diaphragmatic/phrenic nerve laparoscopically-implanted stimulator
- Decision date
- 2023-03-31
- Decision code
- APPR
- Date received
- 2020-03-12
- Approval order statement
- Approval for the NeuRx DPS® is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. For use only in patients 18 years of age or older.