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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.
Classification Namemonitor, intracranial pressure, implanted
Generic Namemonitor, intracranial pressure, implanted
Integra LifeSciences Corp.
22 terry avenue
burlington, MA 01803
PMA NumberP820012
Supplement NumberS006
Date Received08/03/1998
Decision Date07/29/1999
Product Code
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a polypropylene connector to the ventricular catheter side of the Tele-Sensor(R).