← FDA Medical Device Classifications
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
PSR · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
- FDA Product Code
PSR- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- —
- Review panel
- AN
- Medical specialty
- Unknown
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
The device is intended to stimulate the phrenic nerve to produce diaphragm movement during sleep.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 3
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown