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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.
 
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
Supplement NumberS002
Date Received09/17/1990
Decision Date11/15/1990
Product Code
GZE[ Registered Establishments with GZE ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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