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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.
 
DeviceMEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
180 Wells Ave, Suite 300A
Newton, MA 02459
PMA NumberP890055
Supplement NumberS055
Date Received04/28/2014
Decision Date05/22/2014
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 CHANGES TO QUALITY CONTROL AND MANUFACTURING PROCEDURES TO INCLUDE ADDITIONAL STEPS VERIFYING THAT A MINIMUM OF 66 HOURS HAVE ELAPSED BETWEEN THE TIME THAT THE MEDSTREAM PUMP BATTERY IS CONNECTED TO THE PRINTED CIRCUIT BOARD (PCB) AND BEFORE PROGRAMMING THE PCB WITH THE PRODUCTION DIAGNOSTIC PUMP SOFTWARE.
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