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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
medtronic synchromed infusion system

supplement #: S205
Medtronic, Inc. Feb 25, 2015 change design/components/specifications/material  
medtronic synchromed ii programmable drug infusion system

supplement #: S206
Medtronic, Inc. Oct 20, 2014 change design/components/specifications/material  
drug delivery infusion

supplement #: S207
Medtronic, Inc. Jun 27, 2014 process change - manufacturer/sterilizer/packager/supplier  
synchromed system

supplement #: S208
Medtronic, Inc. Jul 03, 2014 process change - manufacturer/sterilizer/packager/supplier  
drug delivery catheters

supplement #: S209
Medtronic, Inc. Jul 24, 2014 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system

supplement #: S210
Medtronic, Inc. Aug 14, 2014 labeling change - indications/instructions/shelf life/tradename  
medtronic synchromed ii infusion systems

supplement #: S211
Medtronic, Inc. Sep 12, 2014 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system

supplement #: S212
Medtronic, Inc. Oct 08, 2014 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system

supplement #: S213
Medtronic, Inc. Oct 03, 2014 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion systen

supplement #: S214
Medtronic, Inc. Oct 16, 2014 process change - manufacturer/sterilizer/packager/supplier  
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