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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DevicePrometra Programmable Infusion Pump System
Generic Namepump, infusion, implanted, programmable
ApplicantFLOWONIX MEDICAL, INC.
500 international drive
suite 200
mt.olive, NJ 07828
PMA NumberP080012
Supplement NumberS068
Date Received11/05/2020
Decision Date01/12/2022
Product Code LKK 
Docket Number 22M-0090
Notice Date 01/25/2022
Advisory Committee General Hospital
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Prometra® Programmable Infusion Pump System. The device is indicated for intrathecal infusion of drug therapy, including: Infumorph ® (preservative free morphine sulfate sterile solution), preservative-free sterile 0.9% saline solution (Sodium Chloride Injection, USP), and baclofen (baclofen injection, intrathecal, 500-2000 mcg/mL). For Infumorph, the pump system is indicated for use in patient populations of 22 years and older (adults). For baclofen, the pump system is indicated for use in patient populations of 12 years and older (pediatric adolescents and adults).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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