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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 INFUSION
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave. NE
Minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS081
Date Received01/13/2006
Decision Date03/22/2006
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH 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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