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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 NumberS005
Date Received07/07/1995
Decision Date07/09/1996
Product Code
GZE[ Registered Establishments with GZE ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in manufacturing facility to avery laboratories inc. , commack, new york.
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