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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 NameSYNCHROMED II PROGRAMMABLE PUMP
Classification Namepump, infusion, implanted, programmable
Applicant MEDTRONIC INC.
PMA NumberP860004
Supplement NumberS158
Date Received10/12/2011
Decision Date12/09/2011
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
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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