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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: PERCUTANEOUS INTRASPINAL CATHETER KIT
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS078
Date Received11/23/2005
Decision Date03/10/2006
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR INCLUSION OF THE B. BRAUN MEDICAL PERIFIX CATHETER CONNECTOR IN THE MODEL 8516 PERCUTANEOUS INTRASPINAL CATHETER KIT.
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