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 | CURESIS PLASMA SEPARATOR |
| Generic Name | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | ORGANON TEKNIKA CORP. |
| Date Received | 1983-03-02 |
| Decision Date | 1984-09-19 |
| Notice Date | 1984-11-09 |
| PMA | P830010 |
| Supplement | S |
| Product Code | LKN |
| Docket Number | 84M-0338 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ORGANON TEKNIKA CORP. 5300 South Portland Ave. oklahoma City, OK 73119 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P830010 | Original Filing | |
| S003 | 1985-07-30 | |
| S002 | ||
| S001 | 1984-11-19 |