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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 & ISOMED DRUG INFUSION SYSTEMS
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS114
Date Received10/01/2009
Decision Date10/30/2009
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 FOR CHANGES TO THE IMPLANT MANUALS FOR THE FOLLOWING SUTURELESS CONNECTOR CATHETERS: MODEL 8709SC INDURA 1P ONE-PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR, MODEL 8731SC INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR, MODEL 8578 SUTURELESS PUMP CONNECTOR REVISION KIT, AND MODEL 8696SC INTRATHECAL CATHETER PUMP SEGMENT REVISION KIT WITH SUTURELESS CONNECTOR.
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