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. |
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Device | PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM |
Generic Name | CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL |
Applicant | SMITHS MEDICAL ASD, INC. 1265 Grey Fox Road St. Paul, MN 55112 |
PMA Number | P900052 |
Supplement Number | S018 |
Date Received | 04/22/2013 |
Decision Date | 05/13/2013 |
Withdrawal Date
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12/26/2018 |
Product Code |
LNY |
Advisory Committee |
General Hospital |
Supplement Type | 30-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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