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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 NamePORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST
Classification Namecatheter, percutaneous, long term, intraspinal
Generic Namelong term epidural access system
ApplicantSIMS DELTEC, INC.
PMA NumberP900052
Supplement NumberS004
Date Received02/23/1996
Decision Date05/23/1997
Product Code
LNY
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in indications for use to include long-term, repeated access to the epidural space for the delivery of preservative-free morphine sulfate to relieve chronic intractable pain of non-malignant origin.
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