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. |
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Device | Aptima HPV Assay |
Generic Name | Kit, rna detection, human papillomavirus |
Applicant | GEN-PROBE INCORPORATED 10210 Genetic Center Drive San Diego, CA 92121 |
PMA Number | P100042 |
Supplement Number | S013 |
Date Received | 09/01/2017 |
Decision Date | 02/28/2018 |
Product Code |
OYB |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the use of the Aptima HPV Assay on Panther Systems equipped with the Panther Fusion Module. The changes required for addition of the Panther Fusion Module that are subject of this approval include reconfiguration of the Panther system hardware and updates to the Panther System and Aptima HPV Assay software. |
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