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 | CRYOMAX(TM) |
| Generic Name | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | STRATO MEDICAL CORP. |
| Date Received | 1983-03-15 |
| Decision Date | 1983-04-26 |
| PMA | P820002 |
| Supplement | S001 |
| Product Code | LKN |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | STRATO MEDICAL CORP. pfizer Hospital Products Group 123 Brimbal Ave beverly, MA 01915 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P820002 | Original Filing | |
| S002 | 1983-05-02 | |
| S001 | 1983-03-15 |