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U.S. Department of Health and Human Services

Devices@FDA
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Note: if a medical device has supplements, the device description and instructions may have
changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
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438 supplements returned for P860004

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Device Name Company Date Approved Supplement Reason Other Information
synchromed ii programmable pump

supplement #: S185
Medtronic, Inc. Nov 09, 2015 change design/components/specifications/material  
drug delivery infusion pumps synchromed family

supplement #: S186
Medtronic, Inc. Feb 25, 2013 process change - manufacturer/sterilizer/packager/supplier  
n vision programmer

supplement #: S187
Medtronic, Inc. Jun 18, 2013 change design/components/specifications/material  
synchromed ii pump

supplement #: S188
Medtronic, Inc. Mar 22, 2013 process change - manufacturer/sterilizer/packager/supplier  
medtronic synchromed infusion systems

supplement #: S189
Medtronic, Inc. Sep 09, 2015 change design/components/specifications/material  
synchromed ii infusion pump

supplement #: S190
Medtronic, Inc. Apr 17, 2013 process change - manufacturer/sterilizer/packager/supplier  
synchromed pump and infusion system

supplement #: S191
Medtronic, Inc. May 23, 2013 labeling change - indications/instructions/shelf life/tradename  
synchromed ii drug pump

supplement #: S192
Medtronic, Inc. Aug 01, 2013 process change - manufacturer/sterilizer/packager/supplier  
synchromed ii and synchromed el drug pumps

supplement #: S193
Medtronic, Inc. Aug 05, 2013 process change - manufacturer/sterilizer/packager/supplier  
synchromed ii infusion pump

supplement #: S194
Medtronic, Inc. Aug 27, 2013 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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