PMA P100033S005
- Device
- PROGENSA PCA3 ASSAY
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100033
- Supplement
- S005
- Product code
- OYM
- Decision date
- 2015-07-09
- Classification
- Prostrate Cancer Genes Nucleic Acid Amplification Test System
- Generic name
- Prostrate cancer genes nucleic acid amplification test system
- Approval order statement
- EXTENSION OF THE PRE-CLEANING AND POST-CLEANING HOLD TIMES FOR AUTOMATED CLEANING OF STAINLESS STEEL TANKS USED IN THE MANUFACTURE OF THE SELECTION REAGENT FOR THE PROGENSA PCA3 ASSAY. IN ADDITION, A MANUAL CLEANING PROCESS OPTION IS ADDED FOR THE STAINLESS STEEL TANKS AS A BACKUP METHOD.
Current openFDA PMA Record#
- Device
- PROGENSA PCA3 ASSAY
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100033
- Supplement
- S005
- Product code
- OYM
- Generic name
- Prostrate cancer genes nucleic acid amplification test system
- Decision date
- 2015-07-09
- Decision code
- OK30
- Date received
- 2015-06-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- EXTENSION OF THE PRE-CLEANING AND POST-CLEANING HOLD TIMES FOR AUTOMATED CLEANING OF STAINLESS STEEL TANKS USED IN THE MANUFACTURE OF THE SELECTION REAGENT FOR THE PROGENSA PCA3 ASSAY. IN ADDITION, A MANUAL CLEANING PROCESS OPTION IS ADDED FOR THE STAINLESS STEEL TANKS AS A BACKUP METHOD.