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.
| Device | COBE CENTRY(R) TPE SYSTEM |
| Generic Name | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | GAMBRO BCT, INC. |
| Date Received | 1993-04-19 |
| Decision Date | 1994-07-05 |
| PMA | P810023 |
| Supplement | S002 |
| Product Code | LKN |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GAMBRO BCT, INC. 10811 West Collins Ave. lakewood, CO 80215 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P810023 | Original Filing | |
| S002 | 1993-04-19 | Normal 180 Day Track |
| S001 |