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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 IMPLANTABLE INFUSION SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS061
Date Received05/19/2004
Decision Date06/04/2004
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 A CHANGE TO THE MEDTRONIC MODEL 8840 N'VISION PROGRAMMER TECHNICAL MANUAL TO ADD A PRECAUTION TO IDENTIFY AN ENVIRONMENT IN WHICH THE DEVICE IS NOT CERTIFIED FOR USE.
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