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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
medtronic(r) synchromed(tm) pump & infusion system

supplement #: S439
Medtronic, Inc. Feb 13, 2025 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system; ascenda intrathecal catheters

supplement #: S440
Medtronic, Inc. Mar 14, 2025 process change - manufacturer/sterilizer/packager/supplier  
synchromed® infusion system, ascenda® intrathecal catheters

supplement #: S441
Medtronic, Inc. Mar 14, 2025 process change - manufacturer/sterilizer/packager/supplier  
synchromed® infusion system, ascenda ® intrathecal catheters

supplement #: S442
Medtronic, Inc. May 21, 2025 process change - manufacturer/sterilizer/packager/supplier  
synchromed ™ infusion system, ascenda ® intrathecal catheters

supplement #: S443
Medtronic, Inc. Jan 20, 2026 process change - manufacturer/sterilizer/packager/supplier  
synchromed® infusion system, ascenda® intrathecal catheters

supplement #: S444
Medtronic, Inc. Jun 18, 2025 process change - manufacturer/sterilizer/packager/supplier  
synchromed® infusion system, ascenda® intrathecal catheters

supplement #: S445
Medtronic, Inc. Jul 17, 2025 process change - manufacturer/sterilizer/packager/supplier  
synchromed™ infusion system, ascenda™ intrathecal catheters

supplement #: S446
Medtronic, Inc. Jul 17, 2025 process change - manufacturer/sterilizer/packager/supplier  
synchromed™ infusion system, ascenda™ intrathecal catheters

supplement #: S447
Medtronic, Inc. Aug 28, 2025 process change - manufacturer/sterilizer/packager/supplier  
synchromed infusion system, ascenda intrathecal catheters

supplement #: S448
Medtronic, Inc. Aug 29, 2025 labeling change - indications/instructions/shelf life/tradename  
  We welcome your comments and feedback about Devices@FDA.
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