PMA P080014S005
- Device
- CERVISTA HPV HR
- Applicant
- Hologic, Inc.
- PMA number
- P080014
- Supplement
- S005
- Product code
- MAQ
- Decision date
- 2011-03-29
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- APPROVAL FOR THE INCREASE OF THE VOLUME OF THE HPV CONTROL IN CERVISTA HPV HR TEST AND LABELING CHANGES TO THE PACKAGE INSERT.
Current openFDA PMA Record#
- Device
- CERVISTA HPV HR
- Applicant
- Hologic, Inc.
- PMA number
- P080014
- Supplement
- S005
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2011-03-29
- Decision code
- APPR
- Date received
- 2010-10-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE INCREASE OF THE VOLUME OF THE HPV CONTROL IN CERVISTA HPV HR TEST AND LABELING CHANGES TO THE PACKAGE INSERT.