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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
ApplicantInfusyn Therapeutics, LLC
121 Shelley Dr.
2h
Hackettstown, NJ 07840
PMA NumberP080012
Supplement NumberS073
Date Received07/12/2024
Decision Date08/09/2024
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
change to the ethylene oxide sterilization dosage
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