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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

supplement #: S307
Medtronic, Inc. Jun 06, 2018 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system, ascenda intrathecal catheters

supplement #: S308
Medtronic, Inc. Jun 01, 2018 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system, and ascenda intrathecal catheters

supplement #: S309
Medtronic, Inc. Jun 15, 2018 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system

supplement #: S310
Medtronic, Inc. Jun 19, 2018 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system, ascenda intrathecal catheters

supplement #: S311
Medtronic, Inc. Aug 22, 2018 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system

supplement #: S312
Medtronic, Inc. Jul 18, 2018 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system, ascenda intrathecal catheters

supplement #: S313
Medtronic, Inc. Jul 30, 2018 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system, ascenda intrathecal catheters

supplement #: S314
Medtronic, Inc. Jul 24, 2018 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system

supplement #: S315
Medtronic, Inc. Aug 14, 2018 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system, ascends intrathecal catheters

supplement #: S316
Medtronic, Inc. Jun 14, 2019 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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