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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
ApplicantInfusyn Therapeutics, LLC
121 Shelley Drive
2H
Hackettstown, NJ 07840
PMA NumberP080012
Supplement NumberS057
Date Received03/19/2019
Decision Date01/15/2020
Product Code LKK 
Advisory Committee General Hospital
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for change in the sourcing of the lubricant chemical and in the resin tint blends to not include a carrier for two syringes and a stop cock which are components in the Prometra II® Programmable Infusion Pump Accessories the Refill Kit and the Catheter Access Port Kit.
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