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 in the sterilant form 12% freon/ 88% ethylene oside to 100% ethylene oxide and to change the sterilization facility from davol, inc. , a c. R. Bard facility in cranston, r. I. , to a contract sterilizer, sorex medical, inc. , in salt lake city, utah.
| 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 | 1997-05-05 |
| Decision Date | 1997-08-08 |
| PMA | P860064 |
| Supplement | S008 |
| Product Code | LNY |
| Advisory Committee | General Hospital |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |