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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 NameARROW OR PUMP HEATER & AP-07009 FLEX TIP PLUS INTRASPINAL KIT
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
ApplicantARROW INTL., INC.
PMA NumberP890055
Supplement NumberS012
Date Received04/02/2001
Decision Date04/24/2001
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of: 1) an or pump heater (ap-09100) and drape (ap-09150) as an option to the traditional water bath; 2) a micropipette or prep kit (ap-07004) for the measurement of flow from the implantable pump prior to implantation; and 3) accessories to the intraspinal kit (ap-07009), including an additional needle and both winged and traditional catheter anchors.
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