This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | COBE CENTRY(R) TPE SYSTEM |
| Generic Name | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | GAMBRO BCT, INC. |
| Date Received | 1981-05-18 |
| Decision Date | 1982-03-16 |
| Notice Date | 1982-04-09 |
| PMA | P810023 |
| Supplement | S |
| Product Code | LKN |
| Advisory Committee | Gastroenterology/Urology |
| 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 |