PMA P080014S013
- Device
- CERVISTA HUMAN PAPILLOMA VIRUS (HPV)
- Applicant
- Hologic, Inc.
- PMA number
- P080014
- Supplement
- S013
- Product code
- MAQ
- Decision date
- 2012-07-03
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- CHANGE IN THE CLINICAL DEVELOPMENT DATABASE SOFTWARE FROM VERSION 5.9 TO VERSION 6.0.
Current openFDA PMA Record#
- Device
- CERVISTA HUMAN PAPILLOMA VIRUS (HPV)
- Applicant
- Hologic, Inc.
- PMA number
- P080014
- Supplement
- S013
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2012-07-03
- Decision code
- OK30
- Date received
- 2012-06-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE CLINICAL DEVELOPMENT DATABASE SOFTWARE FROM VERSION 5.9 TO VERSION 6.0.