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 modifications to the instructions for use (ifu) for the dupen long term epidural catheter and the dupen catheter repair kit. These six modifications are: 1) to delete references to resterilization of product; 2) to add a caution to the repair kit ifu to examine the package and not use or resterilize if package is damaged; 3) to add the prescription statement to the repair kit ifu; 4) to add international units of measurea nd general international requirements; 5) to add a general biohazard statement concerning handling of product after use to the ifus and product labels; and 6) to add an international symbol (explained in the device ifu) tot he external catheter sleeve "attention, see instructions for use. "
| Device | DUPEN LONG TERM EPIDURAL CATHETER |
| Classification Name | Catheter, Percutaneous, Long Term, Intraspinal |
| Generic Name | Catheter, Percutaneous, Long Term, Intraspinal |
| Applicant | C.R. Bard, Inc. |
| Date Received | 1998-01-15 |
| Decision Date | 1998-01-26 |
| PMA | P860064 |
| Supplement | S009 |
| 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 | C.R. Bard, Inc. 605 N 5600 W salt Lake City, UT 84116 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860064 | Original Filing | |
| S010 | 2001-11-14 | 30-day Notice |
| S009 | 1998-01-15 | Real-time Process |
| S008 | 1997-05-05 | Normal 180 Day Track |
| S007 | ||
| S006 | 1991-02-27 | Normal 180 Day Track |
| S005 | 1990-09-07 | Normal 180 Day Track |
| S004 | 1989-12-27 | Normal 180 Day Track |
| S003 | 1989-07-24 | Normal 180 Day Track |
| S002 | 1988-09-06 | Normal 180 Day Track |
| S001 | 1988-08-22 | Normal 180 Day Track |