PMA P080014S015
- Device
- CERVISTA HPV HR, GENFIND DNA EXTRACTION KIT
- Applicant
- Hologic, Inc.
- PMA number
- P080014
- Supplement
- S015
- Product code
- MAQ
- Decision date
- 2013-04-18
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- APPROVAL FOR A MINOR LABELING CHANGE IN THE CERVISTA OPERATOR¿S MANUAL.
Current openFDA PMA Record#
- Device
- CERVISTA HPV HR, GENFIND DNA EXTRACTION KIT
- Applicant
- Hologic, Inc.
- PMA number
- P080014
- Supplement
- S015
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2013-04-18
- Decision code
- APPR
- Date received
- 2012-12-19
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A MINOR LABELING CHANGE IN THE CERVISTA OPERATOR¿S MANUAL.