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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.
 
DeviceMEDTRONIC SYNCHROMED INFUSION
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
MEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS081
Date Received01/13/2006
Decision Date03/22/2006
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Recalls CDRH Recalls
Approval Order Statement 
APPROVAL FOR THE FOLLOWING CHANGES: 1) ADDING A SUTURELESS PUMP CONNECTOR TO BOTH MODELS 8709 AND 8731 CATHETERS COMPATIBLE WITH THE SYNCHROMED AND ISOMED IMPLANTABLE INFUSION PUMPS; 2) ADDING NUMBERS (IN CENTIMETERS) TO THE MARKINGS ON THE 8709 CATHETER BODY LIKE THOSE ON THE 8731 CATHETER; 3) ADDING A SHORTER (9.3 CM) INTRODUCER NEEDLE TO THE MODEL 8731 KIT; 4) ADDING CONNECTOR PINS AND STRAIN RELIEF SLEEVES TO MODEL 8731 CATHETER KIT ALLOWING THE PUMP SEGMENT OF THE CATHETER TO BE TRIMMED; 5) CREATE MODEL 8578 AS A REVISION KIT FOR 8709 OR 8709SC (SUTURELESS CONNECTOR) CONTAINING THE SUTURELESS CONNECTOR SEGMENT AND STRAIN RELIEF SLEEVES; 6) ADDING MODEL 8598A FOR CURRENT 8598 KIT (8731 SPINAL CATHETER SEGMENT REVISION KIT) MODIFIED TO CONTAIN THE SHORTER (9.3 CM) INTRODUCER NEEDLE; AND 7) MODEL 8596SC AS THE PUMP CONNECTOR IN THE CURRENT 8596 KIT (8731 PUMP CATHETER SEGMENT REVISION KIT) WAS REPLACED WITH THE SUTURELESS PUMP CONNECTOR.
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