PMA P210029S001
- Device
- Aptima CMV Quant Assay
- Applicant
- Hologic, Inc.
- PMA number
- P210029
- Supplement
- S001
- Product code
- PAB
- Decision date
- 2022-07-20
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- Add additional monitoring and final release criteria.
Current openFDA PMA Record#
- Device
- Aptima CMV Quant Assay
- Applicant
- Hologic, Inc.
- PMA number
- P210029
- Supplement
- S001
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2022-07-20
- Decision code
- OK30
- Date received
- 2022-06-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add additional monitoring and final release criteria.