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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 Drive
San Diego, CA 92121
PMA NumberP120007
Supplement NumberS004
Date Received03/04/2015
Decision Date04/01/2015
Product Code OYB 
Advisory Committee Microbiology
Clinical TrialsNCT01384370
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
SCALE-UP OF A BULK SOLUTION, INCREASE IN THE BULK HOLD TIME, AND QUALIFICATION OF A NEW MANUFACTURING FILLING SYSTEM.
Post-Approval StudyShow Report Schedule and Study Progress
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