This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYSTEM |
| Generic Name | Catheter, Percutaneous, Long Term, Intraspinal |
| Applicant | SMITHS MEDICAL ASD, INC. |
| Date Received | 1990-07-19 |
| Decision Date | 1991-04-22 |
| Notice Date | 1991-06-07 |
| PMA | P900052 |
| Supplement | S |
| Product Code | LNY |
| Docket Number | 91M-0167 |
| Advisory Committee | General Hospital |
| 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 |