Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceCOSMAN ICP TELE-SENSOR(R)
Generic NameMonitor, intracranial pressure, implanted
ApplicantIntegra Lifesciences Corp.
22 Terry Ave.
Burlington, MA 01803
PMA NumberP820012
Supplement NumberS006
Date Received08/03/1998
Decision Date07/29/1999
Withdrawal Date09/20/2011
Product Code LII 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of a polypropylene connector to the ventricular catheter side of the Tele-Sensor(R).
-
-