CERVISTA
FDA premarket approval P080015/S003 · decided 2011-02-03
Approval details
- PMA number
- P080015
- Supplement
- S003
- Supplement type
- Real-Time Process
- Trade name
- CERVISTA
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Hologic, Inc.
- Date received
- 2011-01-18
- Decision date
- 2011-02-03
- Days to decision
- 16 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR SEVERAL CHANGES TO THE CERVISTA HPV 16/18 SOFTWARE AND LABELING. CHANGES INCLUDE THE COMPANY NAME CHANGE FROM THIRD WAVE TO HOLOGIC, NUMEROUS USER INTERFACE CHANGES, AND SEPARATING THE INVADER CALL REPORTER AND CERVISTA HPV 16/18 SOFTWARE ON TO SEPARATE CDS WITH NEW PART NUMBERS.
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