NeuRX Diaphragm Pacing System (DPS)
FDA premarket approval P200018 · decided 2023-03-31
Approval details
- PMA number
- P200018
- Trade name
- NeuRX Diaphragm Pacing System (DPS)
- Generic name
- diaphragmatic/phrenic nerve laparoscopically-implanted stimulator
- Applicant
- Synapse Biomedical, Inc.
- Date received
- 2020-03-12
- Decision date
- 2023-03-31
- Days to decision
- 1114 days
- Decision code
- APPR
- Product code
- OIR
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Oberline, OH
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Synchrony (20-3000) (K242704) | Synapse Biomedical, Inc. | 2025-06-05 |