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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.
 
Trade NameDUPEN LONG-TERM EPIDURAL CATHETER
Classification Namecatheter, percutaneous, long term, intraspinal
Generic Namelong-term epidural access catheter-morphine
ApplicantC.R. BARD, INC.
PMA NumberP860064
Supplement NumberS010
Date Received11/14/2001
Decision Date12/07/2001
Product Code
LNY[ Registered Establishments with LNY ]
Advisory Committee General Hospital
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Manufacturing change in eto sterilization cycle parameters.
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