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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameimplanted diaphragmatic/phrenic nerve stimulator
Generic Nameimplanted diaphragmatic/phrenic nerve stimulator
Regulation Number882.5830
61 mall dr.
commack, NY 11725-5703
PMA NumberP860026
Supplement NumberS007
Date Received11/16/2000
Decision Date01/26/2001
Product Code
GZE[ Registered Establishments with GZE ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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.