PMA P100033S003
- Device
- PROGENSA PCA3 ASSAY
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100033
- Supplement
- S003
- Product code
- OYM
- Decision date
- 2015-04-16
- Classification
- Prostrate Cancer Genes Nucleic Acid Amplification Test System
- Generic name
- Prostrate cancer genes nucleic acid amplification test system
- Approval order statement
- MANUFACTURING SCALE UP OF BULK ENZYME RECONSTITUTION SOLUTION (P/N BS0421), BY ALLOWING BULKING AND FILLING FROM LARGER TANKS (208L AND 303L) AND ADDITIONALLY, TOEXTEND THE BULK HOLD TIME FROM 7 DAYS UP TO 1 MONTH TO ALLOW SUFFICIENT TIME FOR THE SOLUTION TO BE USED WITHIN MANUFACTURING.
Current openFDA PMA Record#
- Device
- PROGENSA PCA3 ASSAY
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100033
- Supplement
- S003
- Product code
- OYM
- Generic name
- Prostrate cancer genes nucleic acid amplification test system
- Decision date
- 2015-04-16
- Decision code
- OK30
- Date received
- 2015-03-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURING SCALE UP OF BULK ENZYME RECONSTITUTION SOLUTION (P/N BS0421), BY ALLOWING BULKING AND FILLING FROM LARGER TANKS (208L AND 303L) AND ADDITIONALLY, TOEXTEND THE BULK HOLD TIME FROM 7 DAYS UP TO 1 MONTH TO ALLOW SUFFICIENT TIME FOR THE SOLUTION TO BE USED WITHIN MANUFACTURING.