|
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 | S044 |
Date Received | 05/31/2017 |
Decision Date | 06/29/2017 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | special (immediate track) |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of updated labeling to the Flowonix Prometra Programmable Infusion Pump System Instructions for Use. |