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 Implantable Pump / Prometra II Programmable Implantable Pump |
Generic Name | pump, infusion, implanted, programmable |
Applicant | FLOWONIX MEDICAL, INC. 500 international drive suite 200 mt.olive, NJ 07828 |
PMA Number | P080012 |
Supplement Number | S047 |
Date Received | 09/19/2017 |
Decision Date | 12/19/2017 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | real-time process |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modifications of product labeling as a result of MRI testing conducted on the Flowonix Prometra Programmable Infusion Pump System. |
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