PMA P000021
- Device
- Dimension TPSA Flex reagent cartridge
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P000021
- Supplement
- S044
- Product code
- LTJ
- Decision date
- 2025-05-22
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Approval order statement
- Transfer of Service Spare Parts Production to Contract Manufacturer.
Current openFDA PMA Record#
- Device
- Dimension TPSA Flex reagent cartridge
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P000021
- Supplement
- S047
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Decision date
- 2025-05-22
- Decision code
- OK30
- Date received
- 2025-04-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of Service Spare Parts Production to Contract Manufacturer.