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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.
 
DeviceARROW OR PUMP HEATER & AP-07009 FLEX TIP PLUS INTRASPINAL KIT
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
CODMAN
325 paramount dr.
raynham, MA 02767
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 change design/components/specifications/material
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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