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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
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 NumberS016
Date Received08/11/2008
Decision Date04/20/2009
Product Code
LNY[ Registered Establishments with LNY ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A LABEL CLAIM ¿DOES NOT CONTAIN NATURAL RUBBER LATEX.¿
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