PMA P080014S012
- Device
- CERVISTA HPV HR
- Applicant
- Hologic, Inc.
- PMA number
- P080014
- Supplement
- S012
- Product code
- MAQ
- Decision date
- 2012-05-21
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- APPROVAL FOR A SOFTWARE REVISION CHANGE FROM CERVISTA HPV HR V5.4 TO CERVISTA HPV HR V6.0.
Current openFDA PMA Record#
- Device
- CERVISTA HPV HR
- Applicant
- Hologic, Inc.
- PMA number
- P080014
- Supplement
- S012
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2012-05-21
- Decision code
- APPR
- Date received
- 2012-04-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A SOFTWARE REVISION CHANGE FROM CERVISTA HPV HR V5.4 TO CERVISTA HPV HR V6.0.