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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 infusion system, ascenda intrathecal catheters

supplement #: S297
Medtronic, Inc. Apr 25, 2018 change design/components/specifications/material  
synchromed infusion system

supplement #: S298
Medtronic, Inc. Mar 01, 2018 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system, ascenda intrathecal catheters

supplement #: S299
Medtronic, Inc. Apr 09, 2018 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system

supplement #: S300
Medtronic, Inc. Jun 13, 2018 change design/components/specifications/material  
synchromed infusion system

supplement #: S301
Medtronic, Inc. Apr 25, 2018 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system, ascenda intrathecal catheters

supplement #: S302
Medtronic, Inc. Apr 27, 2018 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system, ascenda intrathecal catheters

supplement #: S303
Medtronic, Inc. May 11, 2018 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system

supplement #: S304
Medtronic, Inc. May 24, 2018 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system, ascenda intrathecal catheters

supplement #: S305
Medtronic, Inc. May 24, 2018 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion sysstem, ascenda intrathecal catheters

supplement #: S306
Medtronic, Inc. May 31, 2018 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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