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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
implantable infusion system

supplement #: S162
Medtronic, Inc. Dec 12, 2011 process change - manufacturer/sterilizer/packager/supplier  
model 855 refill kit

supplement #: S163
Medtronic, Inc. Apr 27, 2012 location change - manufacturer/sterilizer/packager/supplier  
synchromed refill kit/bulk refill kit/synchromed catheter access port (cap) kit

supplement #: S164
Medtronic, Inc. Dec 07, 2011 process change - manufacturer/sterilizer/packager/supplier  
syncromed ii

supplement #: S166
Medtronic, Inc. Dec 28, 2011 process change - manufacturer/sterilizer/packager/supplier  
indura 1 piece intrathecal catheter with sutureless connector/intrathecal catheter with sutureless connector

supplement #: S167
Medtronic, Inc. Feb 17, 2012 change design/components/specifications/material  
synchromed drug pumps

supplement #: S168
Medtronic, Inc. Jun 05, 2012 process change - manufacturer/sterilizer/packager/supplier  
synchromed implantable infusion pump

supplement #: S169
Medtronic, Inc. Jun 07, 2012 process change - manufacturer/sterilizer/packager/supplier  
synchromed ii infusion pump

supplement #: S170
Medtronic, Inc. Jun 06, 2012 process change - manufacturer/sterilizer/packager/supplier  
implantable synchromed ii infusion pump

supplement #: S171
Medtronic, Inc. Jun 18, 2012 process change - manufacturer/sterilizer/packager/supplier  
synchromed ii infusion pump

supplement #: S173
Medtronic, Inc. Aug 21, 2012 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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