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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
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).