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.
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).
| Device | PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM |
| Generic Name | Catheter, Percutaneous, Long Term, Intraspinal |
| Applicant | SMITHS MEDICAL ASD, INC. |
| Date Received | 2013-04-22 |
| Decision Date | 2013-05-13 |
| PMA | P900052 |
| Supplement | S018 |
| Product Code | LNY |
| Advisory Committee | General Hospital |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SMITHS MEDICAL ASD, INC. 1265 Grey Fox Road st. Paul, MN 55112 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P900052 | Original Filing | |
| S018 | 2013-04-22 | 30-day Notice |
| S017 | 2009-09-21 | Real-time Process |
| S016 | 2008-08-11 | Real-time Process |
| S015 | 2007-05-25 | 135 Review Track For 30-day Notice |
| S014 | 2006-12-08 | 135 Review Track For 30-day Notice |
| S013 | 2006-07-26 | 135 Review Track For 30-day Notice |
| S012 | 2002-10-30 | Real-time Process |
| S011 | 2002-09-04 | 30-day Notice |
| S010 | 2001-10-31 | Normal 180 Day Track |
| S009 | 2001-09-11 | 30-day Notice |
| S008 | 1999-09-07 | 30-day Notice |
| S007 | 1999-02-11 | Normal 180 Day Track |
| S006 | 1998-06-04 | Normal 180 Day Track |
| S005 | 1998-04-07 | Normal 180 Day Track |
| S004 | 1996-02-23 | Normal 180 Day Track |
| S003 | 1995-06-26 | Normal 180 Day Track |
| S002 | 1994-06-28 | Normal 180 Day Track |
| S001 |