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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.
 
DevicePORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST
Classification Namecatheter, percutaneous, long term, intraspinal
Generic Namecatheter, percutaneous, long term, intraspinal
Applicant
SMITHS MEDICAL ASD, INC.
1265 grey fox road
st. paul, MN 55112
PMA NumberP900052
Supplement NumberS004
Date Received02/23/1996
Decision Date05/23/1997
Product Code
LNY[ Registered Establishments with 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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