Approval for: 1) the addition of procedural accessories to the port-a-cath epidural system kit, 2) an alternate packaging configuration and 3) change in ethylene oxide residual limits. These added accessories are exactly the same as those described in p900052/s005 for port-a-cath ii epidural low-profile system. The device, as modified, will be marketed under the trade name port-a-cath epidural low profile implantable access system and port-a-cath epidural system kits.
| Device | PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM |
| Generic Name | Catheter, Percutaneous, Long Term, Intraspinal |
| Applicant | SMITHS MEDICAL ASD, INC. |
| Date Received | 2002-10-30 |
| Decision Date | 2002-12-17 |
| PMA | P900052 |
| Supplement | S012 |
| Product Code | LNY |
| Advisory Committee | General Hospital |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SMITHS MEDICAL ASD, INC. 1265 Grey Fox Road st. Paul, MN 55112 |
Supplemental Filings
| 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 | | |
NIH GUDID Devices