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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 Intrathecal Catheters
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS363
Date Received08/26/2020
Decision Date11/18/2020
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a minor design change to the Sutureless Catheter Seal Connector for catheter model number 8731SC and its revision kits model numbers 8578 and 8596SC for the SynchroMed Intrathecal Catheter; as well as the intravascular catheter model number 8201 for the Implantable System for Remodulin.
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