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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 PUMP MODEL 8637
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS116
Date Received11/10/2009
Decision Date12/04/2009
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES TO THE STERILE PACKAGE, SHELF BOX LABEL AND IMPLANT MANUAL TO REFLECT A NEW WARNING WHICH STATES ¿WARNING: KEEP AWAY FROM MAGNETS.¿
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