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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSynchroMed Infusion System and Ascenda Intrathecal Catheters
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS361
Date Received07/20/2020
Decision Date01/15/2021
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of: a material change from polyvinyl chloride (PVC) to Methyl Methacrylate Acrylonitrile Butadiene Styrene (MABS) on the extension set component of the Model 8551 Refill Kit and Model 8540 CAP Kit for the SynchroMed Infusion System.
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