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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 NameINTRATHECAL CATHETER MODELS 8709, 8711, 8709SC, 8731SC, AND REVISION KIT 8598A
Classification Namepump, infusion, implanted, programmable
ApplicantMEDTRONIC NEUROLOGICAL
PMA NumberP860004
Supplement NumberS088
Date Received11/08/2006
Decision Date05/01/2007
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 Yes
Approval Order Statement 
Approval for: 1) a new catheter tip push-out force specification; 2) a modified manufacturing monitoring process to assure conformance to new catheter tip push-out force specification; 3) a change to the catheter tip material for catheter model 8731sc and revision kit model 8598a; and 4) labeling revisions.
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