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.
Approval for a change to the in-process manufacturing package inspection procedure of the port-a-cath epidural and port-a-cath ii low profile epidural systems. The modifications to the in-process pouch seal inspection includes: 1) five test intervals will be performed over a single day versus three test intervals per each manufacturing job. 2) the current five pouches tested using the pull test will be reduced to two pouches per test period and the current two pouches inspected using hand peel and visual verification will be increased to five pouches per test period. 3) the results of the gage pull test and visual inspection will be recorded in the individual job folder per established test interval. 4) the pouch sealing process parameter settings will continue to be recorded for each job and each inspection interval.
| Device | PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS |
| Generic Name | Catheter, Percutaneous, Long Term, Intraspinal |
| Applicant | SMITHS MEDICAL ASD, INC. |
| Date Received | 2006-12-08 |
| Decision Date | 2007-08-28 |
| PMA | P900052 |
| Supplement | S014 |
| Product Code | LNY |
| Advisory Committee | General Hospital |
| Supplement Type | 135 Review Track For 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 |