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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.
 
Trade NameDIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR
Classification Nameimplanted diaphragmatic/phrenic nerve stimulator
Generic Namestimulator, diaphragmatic/phrenic nerve, implant
Regulation Number882.5830
ApplicantAVERY LABORATORIES, INC.
PMA NumberP860026
Supplement NumberS004
Date Received08/10/1993
Decision Date03/03/1998
Product Code
GZE[ Registered Establishments with GZE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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.
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