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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 NameFLEX TIP INTRASPINAL KIT, CATALOG AP-07008
Classification Namepump, infusion, implanted, programmable
ApplicantTHEREX CORP.
PMA NumberP890055
Supplement NumberS005
Date Received09/09/1997
Decision Date12/23/1998
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the flex tip plus intraspinal catheter kit, catalog ap-07008. This catheter kit will be used with the model 3000 implantable pump with bolus safety valve for intraspinal delivery of preservative free morphine to patients with chronic intractable pain.
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