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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
Generic Nameimplanted diaphragmatic/phrenic nerve Stimulator
Regulation Number882.5830
ApplicantAvery Biomedical Devices, Inc.
61 Mall Dr.
Commack, NY 11725
PMA NumberP860026
Supplement NumberS005
Date Received07/07/1995
Decision Date07/09/1996
Product Code GZE 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN MANUFACTURING FACILITY TO AVERY LABORATORIES INC., COMMACK, NEW YORK
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