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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-GT Assay
Generic NameKit, rna detection, human papillomavirus
ApplicantGen-Probe Incorporated
10210 Genetic Center Dr.
San Diego, CA 92121
PMA NumberP120007
Supplement NumberS031
Date Received06/28/2024
Decision Date07/26/2024
Product Code OYB 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a change in a QC test method
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