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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAptima HPV 16 18/45 Genotype Assay
Generic NameKit, rna detection, human papillomavirus
ApplicantGen-Probe Incorporated
10210 Genetic Center Dr.
San Diego, CA 92121
PMA NumberP120007
Supplement NumberS034
Date Received09/26/2025
Decision Date02/03/2026
Product Code OYB 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Aptima HPV 16 18/45 Genotype Assay for expanding the indications to include primary screening.
Post-Approval StudyShow Report Schedule and Study Progress
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