CERVISTA HPV HR
FDA premarket approval P080014/S001 · decided 2009-07-22
Approval details
- PMA number
- P080014
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CERVISTA HPV HR
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Hologic, Inc.
- Date received
- 2009-06-24
- Decision date
- 2009-07-22
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- ADDITIONAL SUPPLIER FOR CERVISTA HPV HR OLIGO MIXES 1, 2, AND 3.
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