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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 EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM
Generic NameCATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
ApplicantSMITHS MEDICAL ASD, INC.
1265 Grey Fox Road
St. Paul, MN 55112
PMA NumberP900052
Supplement NumberS016
Date Received08/11/2008
Decision Date04/20/2009
Withdrawal Date 12/26/2018
Product Code LNY 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A LABEL CLAIM ¿DOES NOT CONTAIN NATURAL RUBBER LATEX.¿
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