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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 NumberS041
Date Received05/01/2017
Decision Date05/31/2017
Product Code LKK 
Advisory Committee General Hospital
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the addition of a dimensional measurement to the current inspection procedure for the Flow Activated Safety Valve (FAV) Access Port Body component to measure the counter-sink depth of the O-ring sealing surface, as specified in change ECO 16-80.
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