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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 AND SYNCHROMED II IMPLANTABLE INFUSION PUMPS
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS059
Date Received02/23/2004
Decision Date03/17/2004
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR: THE ADDITION OF TIME LABELS AND A DAILY DOSE FILED TO THE PROGRAMMING SCREENS; THE ADDITION OF RECENTLY APPROVED CATHETER MODELS, MODEL 8731 AND MODEL 8749, TO THE DROP-DOWN LIST; CHANGES TO THE SCREEN USED TO ENTER THE DEMO MODE, AND THE RESULTING UPDATES TO THE PROGRAMMING GUIDES.
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