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 the addition of a new indication for use. The device, as modified, will be marketed under the trade names acs:180 psa2 assay and acs:centaur psa2 assay and is indicated for the following indications for use: as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (dre) in men aged 50 years or older. Prostatic biopsy is required for the diagnosis of cancer; and as aid in the management of patients with prostate cancer.
| Device | CIBA CORNING ACS PSA IMMUNOASSAY |
| Generic Name | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | BAYER HEALTHCARE, LLC |
| Date Received | 1998-04-20 |
| Decision Date | 1998-12-08 |
| Notice Date | 2000-09-27 |
| PMA | P920030 |
| Supplement | S002 |
| Product Code | LTJ |
| Docket Number | 00M-1536 |
| Advisory Committee | Immunology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BAYER HEALTHCARE, LLC 511 Benedict Ave. tarrytown, NY 10591 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P920030 | Original Filing | |
| S002 | 1998-04-20 | Panel Track |
| S001 | 1995-09-14 | Normal 180 Day Track |