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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 PATIENT THERAPY CONTROLLER
Generic Namepump, infusion, implanted, programmable
ApplicantFLOWONIX MEDICAL, INC.
500 international drive
suite 200
mt.olive, NJ 07828
PMA NumberP080012
Supplement NumberS036
Date Received09/16/2016
Decision Date03/31/2017
Product Code LKK 
Advisory Committee General Hospital
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a hardware change to the Patient Therapy Controller (Catalog No. 12860) that includes an updated Bluetooth Chip and removal of redundant circuitry in the battery protection circuit. This submission also requests an update to the device software (Version 1.02) to accommodate the change in hardware.
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