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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
Generic NamePump, infusion, implanted, programmable
ApplicantAlgorithm Sciences, Inc.
121 Shelley Drive
2H
Hackettstown, NJ 07840
PMA NumberP080012
Supplement NumberS060
Date Received07/25/2019
Decision Date09/23/2019
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 introducing Software Version 2.01.5 for the Prometra Clinician Programmer, Cat. Nos. 12828 and 13828, used with Prometra and Prometra II Programmable Pumps and minor labeling changes to explain reduced functionality accompanying this revision.
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