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 | FLOWONIX MEDICAL, INC. 500 international drive suite 200 mt.olive, NJ 07828 |
PMA Number | P080012 |
Supplement Number | S042 |
Date Received | 05/03/2017 |
Decision Date | 07/21/2017 |
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 electronic component changes occurring in the electronics module of the Flowonix Prometra Infusion Pump. |
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