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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 AND CODMAN 3000 IMPLANTABLE INFUSION PUMP
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
180 Wells Ave., Suite 300a
Newton, MA 02459
PMA NumberP890055
Supplement NumberS061
Date Received09/08/2015
Decision Date10/08/2015
Product Code LKK 
Advisory Committee General Hospital
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGES TO THE STERILIZATION PROCESS: 1) STEAM INJECTION RATE CURRENTLY AT 20 MBAR/MIN WILL CHANGE TO 5 MBAR/MIN; 2) GAS INJECTION RATE CURRENTLY AT 25 MBAR/MIN WILL CHANGE TO 20 MBAR/MIN; 3) MINIMUM PRIMARY DEGASSING TIME OF 10 HOURS WILL CHANGE TO 8 HOURS; 4) THE HANDLES FROM THE STERILIZATION SHIPPER, NUMBER 197548018, WILL BE REMOVED; 5) ADD A SECOND ETHYLENE OXIDE (EO) STERILIZATION CHAMBER (CHAMBER #4; 6) A MINIMUM EO STERILIZATION LOAD IN CHAMBER #3 (EXISTING CHAMBER) AND CHAMBER #4; AND 7) A 2X EO STERILIZATION FOR BOTH CHAMBER #3 AND #4.
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