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 | PLASMA SEPARATION SYSTEM |
| Generic Name | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | FENWAL, INC. |
| Date Received | 1987-07-07 |
| Decision Date | 1987-08-25 |
| PMA | P820032 |
| Supplement | S005 |
| Product Code | LKN |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Other Report |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | FENWAL, INC. three Corporate Drive lake Zurich, IL 60047 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P820032 | Original Filing | |
| S005 | 1987-07-07 | Normal 180 Day Track |
| S004 | 1985-06-07 | |
| S003 | 1984-05-07 | |
| S002 | 1984-04-30 | |
| S001 | 1983-11-22 |