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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
Generic NameCATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
ApplicantSmiths Medical Asd, Inc.
1265 Grey Fox Rd.
St. Paul, MN 55112
PMA NumberP900052
Supplement NumberS004
Date Received02/23/1996
Decision Date05/23/1997
Withdrawal Date12/26/2018
Product Code LNY 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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