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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 Namecatheter, percutaneous, long term, intraspinal
Generic Namecatheter, percutaneous, long term, intraspinal
C.R. Bard, Inc.
605 n 5600 w
salt lake city, UT 84116
PMA NumberP860064
Supplement NumberS008
Date Received05/05/1997
Decision Date08/08/1997
Product Code
LNY[ Registered Establishments with LNY ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the sterilant form 12% freon/ 88% ethylene oside to 100% ethylene oxide and to change the sterilization facility from davol, inc. , a c. R. Bard facility in cranston, r. I. , to a contract sterilizer, sorex medical, inc. , in salt lake city, utah.