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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 CITY, UT 84116
PMA NumberP860064
Supplement NumberS010
Date Received11/14/2001
Decision Date12/07/2001
Withdrawal Date 05/20/2020
Product Code LNY 
Advisory Committee General Hospital
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
MANUFACTURING CHANGE IN ETO STERILIZATION CYCLE PARAMETERS.
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