PMA P920030
- Device
- CIBA CORNING ACS PSA IMMUNOASSAY
- Applicant
- Bayer Healthcare, LLC
- PMA number
- P920030
- Supplement
- S002
- Product code
- LTJ
- Decision date
- 1998-12-08
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Approval order statement
- 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P920030S002B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- CIBA CORNING ACS PSA IMMUNOASSAY
- Applicant
- Bayer Healthcare, LLC
- PMA number
- P920030
- Supplement
- S002
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Decision date
- 1998-12-08
- Decision code
- APPR
- Date received
- 1998-04-20
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- 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.