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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 drug pumps

supplement #: S195
Medtronic, Inc. Oct 10, 2013 process change - manufacturer/sterilizer/packager/supplier  
drug delivery programming systems, n vision programmer

supplement #: S196
Medtronic, Inc. Oct 23, 2013 process change - manufacturer/sterilizer/packager/supplier  
drug delivery catheters, drug delivery infusion pump synchromed family, drug delivery kits for revisions

supplement #: S197
Medtronic, Inc. Oct 22, 2013    
catheters, synchromed, kits

supplement #: S198
Medtronic, Inc. Oct 10, 2013 process change - manufacturer/sterilizer/packager/supplier  
drug delivery infusion pumps synchromed family

supplement #: S199
Medtronic, Inc. Oct 30, 2013 process change - manufacturer/sterilizer/packager/supplier  
synchromed ii drug infusion pump

supplement #: S200
Medtronic, Inc. Oct 28, 2013 process change - manufacturer/sterilizer/packager/supplier  
synchromed ii dug infusion pump

supplement #: S201
Medtronic, Inc. Dec 13, 2013 process change - manufacturer/sterilizer/packager/supplier  
medtronic implantable programmable infusion pumps

supplement #: S202
Medtronic, Inc. Feb 25, 2014 labeling change - indications/instructions/shelf life/tradename  
synchromed ii infusion pump

supplement #: S203
Medtronic, Inc. Apr 10, 2014 process change - manufacturer/sterilizer/packager/supplier  
synchromed ii drug delivery infusion system

supplement #: S204
Medtronic, Inc. Apr 24, 2014 process change - manufacturer/sterilizer/packager/supplier  
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