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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYSTEM
Generic NameCATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
ApplicantSMITHS MEDICAL ASD, INC.
1265 Grey Fox Road
St. Paul, MN 55112
PMA NumberP900052
Date Received07/19/1990
Decision Date04/22/1991
Withdrawal Date 12/26/2018
Product Code LNY 
Docket Number 91M-0167
Notice Date 06/07/1991
Advisory Committee General Hospital
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Supplements:  S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 
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