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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
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS352
Date Received01/17/2020
Decision Date11/10/2020
Product Code LKK 
Advisory Committee General Hospital
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for change of a new sterile packaging (sterile pack) sealing equipment. This change applies to the Refill Kits, Catheter Access Port (CAP) Kit and Catheter Patency Kit in use with the SynchroMed Infusion System Ascenda Intrathecal catheter and Implantable System for remodulin.
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