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.
Eliminate the inspection procedure on some incoming components used in the manufacture of the port-a-cath(r) epidural systems.
| Device | PORT-A-CATH EPIDURAL SYSTEMS |
| Generic Name | Catheter, Percutaneous, Long Term, Intraspinal |
| Applicant | SMITHS MEDICAL ASD, INC. |
| Date Received | 2001-09-11 |
| Decision Date | 2001-10-01 |
| PMA | P900052 |
| Supplement | S009 |
| 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 |