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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 ASSAY
Generic NameKit, rna detection, human papillomavirus
ApplicantGen-Probe Incorporated
10210 Genetic Center Dr.
San Diego, CA 92121
PMA NumberP100042
Supplement NumberS002
Date Received04/17/2014
Decision Date04/29/2014
Product Code OYB 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MINOR SOFTWARE CHANGES FOR THE APTIMA HPV ASSAY SOFTWARE (V2.3.5), THE APTIMA HPV-GT ASSAY SOFTWARE (V2.7.5), PANTHER SYSTEM SOFTWARE (V5.2).
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