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. |
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Device | Prometra Programmable Infusion Pump System, Pump Firmware Patch 0.28 |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Infusyn Therapeutics, LLC 121 Shelley Drive 2H Hackettstown, NJ 07840 |
PMA Number | P080012 |
Supplement Number | S062 |
Date Received | 08/16/2019 |
Decision Date | 10/22/2019 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for introducing Software Version 0.28 for the Prometra II Pumps (REF 13827, 20 mL Pump and Ref 16827, 40 mL Pump). |
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