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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceDIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR
Classification Nameimplanted diaphragmatic/phrenic nerve stimulator
Generic Nameimplanted diaphragmatic/phrenic nerve stimulator
Regulation Number882.5830
Applicant
AVERY BIOMEDICAL DEVICES, INC.
61 mall dr.
commack, NY 11725-5703
PMA NumberP860026
Date Received07/03/1986
Decision Date01/05/1987
Product Code
GZE[ Registered Establishments with GZE ]
Docket Number 87M-0022
Notice Date 02/25/1987
Advisory Committee Anesthesiology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 
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