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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 #: S358
Medtronic, Inc. May 20, 2020 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system and ascenda intrathecal catheters

supplement #: S359
Medtronic, Inc. Jun 09, 2020 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system, ascenda intrathecal catheters

supplement #: S360
Medtronic, Inc. Sep 22, 2020 change design/components/specifications/material  
synchromed infusion system and ascenda intrathecal catheters

supplement #: S361
Medtronic, Inc. Jan 15, 2021 change design/components/specifications/material  
synchromed infusion system and ascenda intrathecal catheters

supplement #: S362
Medtronic, Inc. Sep 09, 2020 process change - manufacturer/sterilizer/packager/supplier  
synchromed intrathecal catheters

supplement #: S363
Medtronic, Inc. Nov 18, 2020 change design/components/specifications/material  
synchromed infusion system, ascenda intrathecal catheters

supplement #: S364
Medtronic, Inc. Nov 19, 2020 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system

supplement #: S365
Medtronic, Inc. Nov 30, 2020 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system and ascenda intrathecal catheters

supplement #: S366
Medtronic, Inc. Dec 18, 2020 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system, ascenda intrathecal catheters

supplement #: S367
Medtronic, Inc. Jan 08, 2021 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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