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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 NumberS008
Date Received09/11/2002
Decision Date03/03/2003
Product Code
GZE[ Registered Establishments with GZE ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for selecting a final value of c22 and c50 capacitors during production testing based on parameters measured with calibrated test equipment to result in peak operating performance of the transmitter.
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