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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 NumberS006
Date Received04/27/2000
Decision Date07/07/2000
Product Code
GZE[ Registered Establishments with GZE ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for process validation of the proposed device sterilization procedure, proposed labeling for the device packaging, and the proposed changes to the instruction manual. The device, as modified, will be marketed under the trade name mark iv and is indicated for persons who require chronic ventilatory support because oof upper motor neuron respiratory muscle paralysis (rmp) or because of central alveolar hypoventilation (cah) and whose remaining phrenic nerve, lung, and diaphragm function.