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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 NumberS003
Date Received06/09/2014
Decision Date07/07/2014
Product Code OYB 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO REVISE AN INTERNAL CONTROL QC RELEASE TEST SPECIFICATION FOR THE APTIMA® HPV ASSAY.
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