CERVISTA HPV 16/18
FDA premarket approval P080015/S007 · decided 2012-05-21
Approval details
- PMA number
- P080015
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CERVISTA HPV 16/18
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Hologic, Inc.
- Date received
- 2012-04-17
- Decision date
- 2012-05-21
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR A SOFTWARE REVISION CHANGE FROM CERVISTA HPV 16/18 V5.4 TO CERVISTA HPV 16/18 V6.0.
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