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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/SYNCHROMED II/ISOMED PUMPS
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP990034
Supplement NumberS020
Date Received09/07/2010
Decision Date10/07/2010
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 ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO UPDATE THE LABELING FOR THESE DEVICES TO SPECIFICALLY STATE CEPHALAD MIGRATION OF CATHETER FRAGMENTS AS PART OF THE ADVERSE EVENT SUMMARIES IN THE DEVICES¿ INFORMATION FOR PRESCRIBERS MANUALS AND USER MANUALS.
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