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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 NumberS039
Date Received02/28/2017
Decision Date03/30/2017
Product Code LKK 
Advisory Committee General Hospital
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for MRI Conditional Labeling changes within the Instructions for Use, Patients Guide, Patient ID Cards which are associated with the Prometra Programmable Pump, Prometra II Programmable Pump, Intrathecal Catheter, and Catheter Revision Kit.
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