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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 NumberS009
Date Received01/15/1998
Decision Date01/26/1998
Product Code
LNY[ Registered Establishments with LNY ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the instructions for use (ifu) for the dupen long term epidural catheter and the dupen catheter repair kit. These six modifications are: 1) to delete references to resterilization of product; 2) to add a caution to the repair kit ifu to examine the package and not use or resterilize if package is damaged; 3) to add the prescription statement to the repair kit ifu; 4) to add international units of measurea nd general international requirements; 5) to add a general biohazard statement concerning handling of product after use to the ifus and product labels; and 6) to add an international symbol (explained in the device ifu) tot he external catheter sleeve "attention, see instructions for use. ".
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