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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 #: S418
Medtronic, Inc. Nov 09, 2023 process change - manufacturer/sterilizer/packager/supplier  
synchromed® infusion system, ascenda® intrathecal catheters

supplement #: S419
Medtronic, Inc. Nov 28, 2023 process change - manufacturer/sterilizer/packager/supplier  
synchromed™ infusion system, ascenda™ intrathecal catheters

supplement #: S420
Medtronic, Inc. Dec 15, 2023 labeling change - indications/instructions/shelf life/tradename  
synchromed® infusion system, ascenda® intrathecal catheters

supplement #: S421
Medtronic, Inc. Jan 11, 2024 process change - manufacturer/sterilizer/packager/supplier  
synchromed® infusion system, ascenda® intrathecal catheters

supplement #: S422
Medtronic, Inc. Feb 16, 2024 process change - manufacturer/sterilizer/packager/supplier  
drug delivery infusion pump

supplement #: S423
Medtronic, Inc. Feb 22, 2024 process change - manufacturer/sterilizer/packager/supplier  
synchromed® infusion system, ascenda® intrathecal catheters

supplement #: S424
Medtronic, Inc. Apr 09, 2024 change design/components/specifications/material  
synchromed infusion system, ascenda intrathecal catheters

supplement #: S425
Medtronic, Inc. Apr 24, 2024 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion systems

supplement #: S426
Medtronic, Inc. May 16, 2024 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system, ascenda intrathecal catheters

supplement #: S427
Medtronic, Inc. May 24, 2024 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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