PMA P100033S011
- Device
- Progensa PCA3 Assay
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100033
- Supplement
- S011
- Product code
- OYM
- Decision date
- 2020-06-08
- Generic name
- Prostrate cancer genes nucleic acid amplification test system
- Approval order statement
- Manufacturing scale-up for reagents.
Current openFDA PMA Record#
- Device
- Progensa PCA3 Assay
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100033
- Supplement
- S011
- Product code
- OYM
- Generic name
- Prostrate cancer genes nucleic acid amplification test system
- Decision date
- 2020-06-08
- Decision code
- OK30
- Date received
- 2020-05-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing scale-up for reagents.