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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DevicePORT-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 NumberS018
Date Received04/22/2013
Decision Date05/13/2013
Product Code
LNY[ Registered Establishments with LNY ]
Advisory Committee General Hospital
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the synthesis of polytetrafluoro-ethylene (ptfe), a substance used in the manufacturing of the coating system for the guidewire contained in the port-a-cath ii low profile epidural implantable access system. This change in the synthesis of ptfe is required to conform to u. S. Environmental agency 2010/2015 pfoa stewardship program related to the use of perfluorooctanoic acid (pfoa).
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