PMA P860026S007
- Device
- DIAPHAGMATIC/PHRENIC NERVE STIMULATOR
- Applicant
- Avery Biomedical Devices, Inc.
- PMA number
- P860026
- Supplement
- S007
- Product code
- GZE
- Decision date
- 2001-01-26
- Classification
- Implanted Diaphragmatic/phrenic Nerve Stimulator
- Generic name
- implanted diaphragmatic/phrenic nerve Stimulator
- Approval order statement
- APPROVAL FOR CHANGING THE METHOD OF ATTACHING THE BATTERY CONNECTOR AND WIRING FROM THE POWER SWITCHES TO THE PRINTED CIRCUIT BOARD, CHANGING THE POINT WHERE THE SIGNAL IS TAKEN TO ILLUMINATE THE BATTERY LED INDICATOR, ADDING THE ENERGY SOURCE ROUTING TO THE FRONT PANEL OF THE RESPIRATORY RATE CONTROL CIRCUITRY, CHANGING THE POINT WHEE THE BATTERY POWER IS OBTAINED FOR EACH STIMULATOR OUTPUT AMPLIFIER CIRCUIT, AND DECREASING THE SENSITIVITY OF THE OSCILLATOR CIRCUIT TO TRANSISTOR OUTPUT CAPACITANCE. 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 CENTRAL ALVEOLAR HYPOVENTILATION (CAH) AND WHOSE REMAINING PHRENIC NERVE, LUNG, AND DIAPHRAGM FUNCTION IS SUFFICIENT TO ACCOMODATE ELECTRICAL STIMULATION.
Current openFDA PMA Record#
- Device
- DIAPHAGMATIC/PHRENIC NERVE STIMULATOR
- Applicant
- Avery Biomedical Devices, Inc.
- PMA number
- P860026
- Supplement
- S007
- Product code
- GZE
- Generic name
- implanted diaphragmatic/phrenic nerve Stimulator
- Decision date
- 2001-01-26
- Decision code
- APPR
- Date received
- 2000-11-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGING THE METHOD OF ATTACHING THE BATTERY CONNECTOR AND WIRING FROM THE POWER SWITCHES TO THE PRINTED CIRCUIT BOARD, CHANGING THE POINT WHERE THE SIGNAL IS TAKEN TO ILLUMINATE THE BATTERY LED INDICATOR, ADDING THE ENERGY SOURCE ROUTING TO THE FRONT PANEL OF THE RESPIRATORY RATE CONTROL CIRCUITRY, CHANGING THE POINT WHEE THE BATTERY POWER IS OBTAINED FOR EACH STIMULATOR OUTPUT AMPLIFIER CIRCUIT, AND DECREASING THE SENSITIVITY OF THE OSCILLATOR CIRCUIT TO TRANSISTOR OUTPUT CAPACITANCE. 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 CENTRAL ALVEOLAR HYPOVENTILATION (CAH) AND WHOSE REMAINING PHRENIC NERVE, LUNG, AND DIAPHRAGM FUNCTION IS SUFFICIENT TO ACCOMODATE ELECTRICAL STIMULATION.