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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
ApplicantInfusyn Therapeutics, LLC
121 Shelley Dr.
2h
Hackettstown, NJ 07840
PMA NumberP080012
Supplement NumberS019
Date Received08/09/2013
Decision Date02/04/2014
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A CATHETER REVISION KIT FOR USE WITH THE SUBJECT SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROMETRA PROGRAMMABLE IMPLANTABLE PUMP SYSTEM AND IS INDICATED FOR INTRATHECAL INFUSION OF INFUMORPH (PRESERVATIVE-FREE MORPHINE SULFATE) OR PRESERVATIVE-FREE STERILE 0.9% SALINE SOLUTION (SODIUM CHLORIDE INJECTION, USP).
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