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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 infusion pump

supplement #: S174
Medtronic, Inc. Aug 21, 2012 process change - manufacturer/sterilizer/packager/supplier  
ascenda intrathecal catheter

supplement #: S175
Medtronic, Inc. Jan 07, 2013 change design/components/specifications/material  
synchromed ii, 8637

supplement #: S176
Medtronic, Inc. Nov 02, 2012 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion systems, synchromed, synchromed ii, synchromed el

supplement #: S177
Medtronic, Inc. Dec 17, 2012 change design/components/specifications/material  
synchromed ii infusion system

supplement #: S178
Medtronic, Inc. Dec 06, 2012 process change - manufacturer/sterilizer/packager/supplier  
synchromed

supplement #: S179
Medtronic, Inc. Dec 20, 2012 labeling change - indications/instructions/shelf life/tradename  
synchromed ii implantable pump, model 8637

supplement #: S180
Medtronic, Inc. Mar 04, 2013 change design/components/specifications/material  
drug delivery accessories,drug delivery catheters,drug delivery infusion pumps synchromed family,drug delivery kits

supplement #: S181
Medtronic, Inc. Jan 08, 2013 process change - manufacturer/sterilizer/packager/supplier  
the synchromed ii implantable pump

supplement #: S182
Medtronic, Inc. Jan 08, 2013 process change - manufacturer/sterilizer/packager/supplier  
model 8880cw medtronic neuromodulation clinician programmer

supplement #: S184
Medtronic, Inc. Jan 08, 2014 change design/components/specifications/material  
  We welcome your comments and feedback about Devices@FDA.
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