PMA P080014S011
- Device
- CERVISTA HPV HR COMPONENTS
- Applicant
- Hologic, Inc.
- PMA number
- P080014
- Supplement
- S011
- Product code
- MAQ
- Decision date
- 2013-02-04
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- APPROVAL FOR SHELF-LIFE EXTENSION OF THE DEVICE FROM 12 MONTHS TO 18 MONTHS.
Current openFDA PMA Record#
- Device
- CERVISTA HPV HR COMPONENTS
- Applicant
- Hologic, Inc.
- PMA number
- P080014
- Supplement
- S011
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2013-02-04
- Decision code
- APPR
- Date received
- 2012-01-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SHELF-LIFE EXTENSION OF THE DEVICE FROM 12 MONTHS TO 18 MONTHS.