Implanted Diaphragmatic/Phrenic Nerve Stimulator
Basic Information
- Device Name
- Implanted Diaphragmatic/Phrenic Nerve Stimulator
- Trade Name
- DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR
- PMA Number
- P860026
- Supplement Number
- S004
- Device Class
- FDA Class 3
- Product Code
- GZE
- Generic Name
- implanted diaphragmatic/phrenic nerve Stimulator
- Regulation Number
- 882.5830
- Medical Specialty
- Neurology
- Advisory Committee
- Anesthesiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 3, 1998
- Date Received
- August 10, 1993
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for bilateral stimulus output redundancy, external breathing rate control, antenna indicators which verify stimulus output and antenna integrity, concealed factory controls, additional covering to the battery connector, and design improvements to existing architecture that do no increase stimulus parameters above what was approved on January 5, 1987. The device, as modified, will be marketed under the trade name mark IV and is indicated for persons who require chronic ventilatory support because of upper motor neuron respiratory muscle paralysis (RMP) or because of contral alveolar hypoventilation (CAH) and whose remaining phrenic nerve, lung, and diaphragm functions is sufficient ota ccommodate electrical stimulation.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GZE | Implanted Diaphragmatic/Phrenic Nerve Stimulator | FDA class 3 | Neurology |