PMA P080014S018
- Device
- CERVISTA HPV HR AND GENFIND KIT
- Applicant
- Hologic, Inc.
- PMA number
- P080014
- Supplement
- S018
- Product code
- MAQ
- Decision date
- 2014-04-29
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- APPROVAL FOR A POST APPROVAL STUDY LABELING UPDATE.
Current openFDA PMA Record#
- Device
- CERVISTA HPV HR AND GENFIND KIT
- Applicant
- Hologic, Inc.
- PMA number
- P080014
- Supplement
- S018
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2014-04-29
- Decision code
- APPR
- Date received
- 2013-07-31
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR A POST APPROVAL STUDY LABELING UPDATE.