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 | CURESIS PLASMA SEPARATOR |
| Generic Name | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma |
| Applicant | ORGANON TEKNIKA CORP. |
| Date Received | 1985-07-30 |
| Decision Date | 1985-12-06 |
| PMA | P830010 |
| Supplement | S003 |
| Product Code | MDP |
| 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 |