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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.
 
DeviceDUPEN LONG TERM EPIDURAL CATHETER
Generic NameCATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
ApplicantC.R. Bard, Inc.
605 N. 5600 W.
Salt Lake Ciy,, UT 84116
PMA NumberP860064
Supplement NumberS008
Date Received05/05/1997
Decision Date08/08/1997
Withdrawal Date05/20/2020
Product Code LNY 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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