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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 NumberS013
Date Received12/20/2017
Decision Date01/18/2018
Product Code OYB 
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Transfer bulk manufacturing and filling operations for specified reagents to an existing manufacturing facility.
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