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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
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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