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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 PLUS INTRASPINAL CATHETER KIT(CATHETER CONNECTOR)
Classification Namepump, infusion, implanted, programmable
Generic Namem3000-50 pump
ApplicantTHEREX CORP.
PMA NumberP890055
Supplement NumberS008
Date Received02/05/1999
Decision Date12/10/1999
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following modifications of the existing flex tip plus intraspinal catheter kit catalog #ap-07008: 1) addition of a "locking feature" to the current catheter connector design to prevent the connector from being inadvertently opened. 2) addition of a "stylet" to the kit. 3) replacement of the blunt flushing needle with the "snap lock flushing adapter". 4) addition of the "threading guide" and the "attachable wing hub". 5) increasing the flex tip plus intraspinal catheter length.
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