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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.
 
DeviceMEDTRONIC SYNCHROMED PUMP HYBRID
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS041
Date Received11/09/1998
Decision Date12/04/1998
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for modifications to the device: 1) Replacement of the quartz crystal oscillator with a surface mount crystal oscillator with the same electrical operating specifications, 2) Replacement of the ceramic wiring board with a fiberglass printed wiring board, 3)Mounting the antenna/reedswitch assembly directly on the wiring board 4) Replacement of the ceramic chip carrier packaging of the microprocessor and integrated circuit with plastic packages, 5) Attachment of the hybrid printed wiring board to the pump center plate with two sided, acrylic adhesive tape rather than a bracket and plastic cup assembly.
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