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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 and ascenda intrathecal catheters

supplement #: S368
Medtronic, Inc. Aug 30, 2021 process change - manufacturer/sterilizer/packager/supplier  
drug delivery infusion pumps synchromed

supplement #: S369
Medtronic, Inc. Mar 25, 2021 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system and ascenda intrathecal catheters

supplement #: S370
Medtronic, Inc. Mar 31, 2021 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system

supplement #: S371
Medtronic, Inc. Apr 01, 2021 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system, ascenda® intrathecai catheters

supplement #: S372
Medtronic, Inc. May 03, 2021 process change - manufacturer/sterilizer/packager/supplier  
synchromed® infusion system

supplement #: S373
Medtronic, Inc. May 04, 2021 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system

supplement #: S374
Medtronic, Inc. Jun 02, 2021 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system, ascenda intrathecal catheters

supplement #: S375
Medtronic, Inc. Jun 25, 2021 process change - manufacturer/sterilizer/packager/supplier  
synchromed® infusion system, ascenda® intrathecal catheters

supplement #: S376
Medtronic, Inc. Jul 21, 2021 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system, ascenda intrathecal catheters

supplement #: S377
Medtronic, Inc. Oct 12, 2021 change design/components/specifications/material  
  We welcome your comments and feedback about Devices@FDA.
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