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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAvery Diaphragm Pacing System (alson known as Breathing Pacemaker System)
Generic Nameimplanted diaphragmatic/phrenic nerve stimulator
Regulation Number882.5830
ApplicantAVERY BIOMEDICAL DEVICES, INC.
61 mall dr.
commack, NY 11725-5703
PMA NumberP860026
Supplement NumberS009
Date Received09/27/2017
Decision Date11/04/2019
Product Code GZE 
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to replace the Mark IV transmitter with the digital Spirit transmitter.
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