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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMEDTRONIC SYNCHROMED PUMP HYBRID
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pumps
ApplicantMEDTRONIC VASCULAR
PMA NumberP860004
Supplement NumberS041
Date Received11/09/1998
Decision Date12/04/1998
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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