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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 IMPLANTABLE PUMP
Generic NamePump, infusion, implanted, programmable
ApplicantInfusyn Therapeutics, LLC
121 Shelley Dr.
2h
Hackettstown, NJ 07840
PMA NumberP080012
Supplement NumberS032
Date Received10/26/2015
Decision Date11/24/2015
Product Code LKK 
Advisory Committee General Hospital
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
TO MODIFY THE MANUFACTURING PROCEDURE FOR THE PATIENT THERAPY CONTROLLER (PTC) TO REROUTE THE PTC'S POWER CABLE WITHIN THE ASSEMBLY TO PREVENT IT FROM DAMAGE. ADDITIONALLY, UPDATE THE FINAL RELEASE TEST TO ADD A "BOLUS TEST" TO FURTHER VERIFY THE OPERATION OF THE PTC PRIOR TO RELEASE.
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