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.
Approval for a change in the method of standardization of the calibrators for the assay
| Device | CIBA CORNING ACS PSA IMMUNOASSAY |
| Generic Name | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | BAYER HEALTHCARE, LLC |
| Date Received | 1995-09-14 |
| Decision Date | 1995-12-13 |
| PMA | P920030 |
| Supplement | S001 |
| Product Code | LTJ |
| Advisory Committee | Immunology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BAYER HEALTHCARE, LLC 511 Benedict Ave. tarrytown, NY 10591 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P920030 | Original Filing | |
| S002 | 1998-04-20 | Panel Track |
| S001 | 1995-09-14 | Normal 180 Day Track |