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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.
 
DevicePROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM CLINICIAN PROGRAMMER
Generic NamePump, infusion, implanted, programmable
ApplicantAlgorithm Sciences, Inc.
121 Shelley Drive
2H
Hackettstown, NJ 07840
PMA NumberP080012
Supplement NumberS037
Date Received09/20/2016
Decision Date12/16/2016
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for clinician programmer software update to add a print tool and implement software/firmware bug fixes.
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