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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 EL PROGRAMMABLE PUMP
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS053
Date Received09/13/2002
Decision Date10/09/2002
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE SYNCHROMED EL PROGRAMMABLE PUMP TECHNICAL MANUAL FOR NEW WARNINGS AND INFORMATION REGARDING INFLAMMATORY MASS, PUMP OVERPRESSURIZATION, DIATHERMY AND OTHER TEXT CHANGES.
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