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U.S. Department of Health and Human Services

Devices@FDA
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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 NumberS446
Date Received06/20/2025
Decision Date07/17/2025
Product Code LKK 
Advisory Committee General Hospital
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
reduced bacterial endotoxin testing frequency and sample size for the Connector Plug Accessory Kit (model B31060), the Bolero Interstim Revision Kit (model 3560031), the Tunneling Tools and Catheter Passers, the Torque Wrenches and Injex families manufactured at Juncos, Puerto Rico facility
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