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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.
 
Trade NameMEDTRONIC MODEL 8749 INTRATHECAL CATHETER
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pumps
ApplicantMEDTRONIC VASCULAR
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 - other
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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