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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, Ascenda® Intrathecal Catheters
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS387
Date Received02/08/2022
Decision Date09/02/2022
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 for a change in the formulation of the resin used in the plastic hub component (Styrene-Butadiene Copolymer), and replacement of the current Urethane Acrylate adhesive (Dymax 1136-M) with another Urethane Acrylate adhesive (Dymax 1405-M-UR-SC), which is used to attach the cannula to the hub.
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