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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 #: S408
Medtronic, Inc. Jul 14, 2023 change design/components/specifications/material  
synchromed® infusion system, ascenda® intrathecal catheters

supplement #: S409
Medtronic, Inc. Jun 02, 2023 process change - manufacturer/sterilizer/packager/supplier  
synchromed® infusion system, ascenda® intrathecal catheters

supplement #: S410
Medtronic, Inc. Jun 07, 2023 process change - manufacturer/sterilizer/packager/supplier  
synchromed® infusion system, ascenda® intrathecal catheters

supplement #: S411
Medtronic, Inc. Jun 07, 2023 process change - manufacturer/sterilizer/packager/supplier  
synchromed® infusion system, ascenda® intrathecal catheters

supplement #: S412
Medtronic, Inc. Jun 21, 2023 process change - manufacturer/sterilizer/packager/supplier  
synchromed® infusion system, ascenda® intrathecal catheters

supplement #: S413
Medtronic, Inc. Aug 03, 2023 process change - manufacturer/sterilizer/packager/supplier  
synchromed® infusion system, ascenda® intrathecal catheters

supplement #: S414
Medtronic, Inc. Aug 10, 2023 process change - manufacturer/sterilizer/packager/supplier  
synchromed® infusion system, ascenda® intrathecal catheters

supplement #: S415
Medtronic, Inc. Nov 28, 2023 change design/components/specifications/material  
synchromed® infusion system, ascenda® intrathecal catheters

supplement #: S416
Medtronic, Inc. Dec 12, 2023 change design/components/specifications/material  
synchromed® infusion system, ascenda ® intrathecal catheters

supplement #: S417
Medtronic, Inc. Oct 18, 2023 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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