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 |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Algorithm Sciences, Inc. 121 Shelley Drive 2H Hackettstown, NJ 07840 |
PMA Number | P080012 |
Supplement Number | S067 |
Date Received | 07/31/2020 |
Decision Date | 10/29/2020 |
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 change to implement a software update of the Clinician Programmer Application Software (2.01.6) to improve Bluetooth connection reliability in Clinician Programmer REF 13828. |
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