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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.
 
DeviceSYNCHROMED II PROGRAMMABLE PUMP
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS158
Date Received09/26/2011
Decision Date12/09/2011
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 THE FOLLOWING: 1) THE ASSEMBLY PROCESS FOR THE ROLLER SUBCOMPONENT OF THE PUMPHEAD CURRENTLY USES A MANUAL PRESS AND WILL BE CHANGED TO USE A MOTORIZED PRESS THAT MONITORS AND CONTROLS TRAVEL DISTANCE AND ASSEMBLY FORCE. THIS CHANGE IS INTENDED TO IMPROVE YIELD AND MANUFACTURING EFFICIENCY; 2) THE MANUFACTURING TOLERANCE FOR THE NON-CRITICAL DIMENSION FOR THE PUMPHEAD ASSEMBLY DEFINED AS THE "STOP POSITION" WILL BE CHANGED FROM 10.77 + 0.044/-0.046 MILLIMETERS TO10.77 +/-0.060 MILLIMETERS. THE CRITICAL COMPONENT SPECIFICATION OF FORCE APPLIED BY THE PUMPHEAD ROLLERS ON THE PUMP TUBE IS NOT CHANGING. THIS CHANGE IS INTENDED TO IMPROVE YIELD OF THE PUMPHEAD COMPONENT; AND 3) THE MANUFACTURING TOLERANCE FOR THE NON-CRITICAL DIMENSION FOR RIVET DIAMETER USED TO ASSEMBLE THE SUPPORT ROLLER ARM SIDES AND SUPPORT ROLLER ARM CENTER IN THE PUMPHEAD ASSEMBLY WILL BE CHANGED FROM 1 +/ -0.002 MILLIMETERS TO 1 +/-0.006 MILLIMETERS. THE RIVETS WILL ALSO BE SORTED BASED ON THE INDIVIDUAL DIAMETER TO MATCH WITH THE DIAMETER OF THE HOLES IN THE ASSEMBLY THEY ARE INSERTED INTO TO PREVENT INTERFERENCE. THE CRITICAL COMPONENT SPECIFICATION OF MINIMUM PRESS OUT FORCE AFTER THE RIVET IS PRESSED INTO PLACE IS NOT CHANGING. THIS CHANGE IS INTENDED TO IMPROVE YIELD OF THE PUMPHEAD COMPONENT.
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