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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 II IMPLANTABLE INFUSION PUMP
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS243
Date Received11/10/2015
Decision Date07/22/2016
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
Approval Order Statement  
Approval for a software change to the Model 8870 Application Software Card to reduce the fixed, default Tubing Volume displayed on the priming bolus screen from 0.199 mL to 0.140 mL. This software card is used in the Model 8840 Clinician Programmer to program the Model 8637 SynchroMed II infusion pump. This change is applicable to the full system priming bolus function of the Model 8840 Clinician Programmer to program the Model 8637 SynchroMed II infusion pump. Labeling changes are also being made in the Instructions for Prescribers, Implant Manual and Clinician Programmer Guide to reflect the software change
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