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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 II Programmable Infusion Pump System
Generic NamePump, infusion, implanted, programmable
ApplicantAlgorithm Sciences, Inc.
121 Shelley Drive
2H
Hackettstown, NJ 07840
PMA NumberP080012
Supplement NumberS065
Date Received02/20/2020
Decision Date03/17/2020
Product Code LKK 
Advisory Committee General Hospital
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Increasing the sterilization load size of Ethylene Oxide sterilized accessories of the Prometra Pump System.
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