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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 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 NumberS018
Date Received04/22/2013
Decision Date05/13/2013
Withdrawal Date 12/26/2018
Product Code LNY 
Advisory Committee General Hospital
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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