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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 NumberS004
Date Received04/20/2012
Decision Date02/13/2013
Product Code LKK 
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR A MODIFICATION TO THE LABELING CLAIM FROM "MR UNSAFE"TO "MR CONDITIONAL" USE.
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