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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.
 
DeviceMEDTRONIC MODEL 8749 INTRATHECAL CATHETER
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
MEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS057
Date Received11/03/2003
Decision Date11/18/2003
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE CHANGES TO THE MODEL 8731 INTRATHECAL CATHETER TO INCLUDE 1) A CHANGE TO THE LENGTH OF PROXIMAL AND DISTAL SEGMENTS OF THE CATHETER; 2) A CHANGE TO THE TUBING CONNECTOR, 3) REVISIONS TO MODEL 8596 AND MODEL 8749 REVISION KITS, 4) REVISIONS TO THE CATHETER TUBING SPECIFICATIONS; AND 5) ADDITION OF A CRIMP SLEEVE TO THE GUIDE WIRE.
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