PMA P860026S004
- Device
- DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR
- Applicant
- Avery Biomedical Devices, Inc.
- PMA number
- P860026
- Supplement
- S004
- Product code
- GZE
- Decision date
- 1998-03-03
- Classification
- Implanted Diaphragmatic/phrenic Nerve Stimulator
- Generic name
- implanted diaphragmatic/phrenic nerve Stimulator
- Approval order 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.
Current openFDA PMA Record#
- Device
- DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR
- Applicant
- Avery Biomedical Devices, Inc.
- PMA number
- P860026
- Supplement
- S004
- Product code
- GZE
- Generic name
- implanted diaphragmatic/phrenic nerve Stimulator
- Decision date
- 1998-03-03
- Decision code
- APPR
- Date received
- 1993-08-10
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.