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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.
 
Trade NamePORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM
Classification Namecatheter, percutaneous, long term, intraspinal
Generic Nameepidural implantable access system
ApplicantSMITHS MEDICAL MD, INC.
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: manufacturing
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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