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 | CERVISTA HPV HR |
Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
Applicant | HOLOGIC, INC. 250 CAMPUS DRIVE MARLBOROUGH, MA 01750 |
PMA Number | P080014 |
Supplement Number | S005 |
Date Received | 10/21/2010 |
Decision Date | 03/29/2011 |
Withdrawal Date
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04/19/2023 |
Product Code |
MAQ |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE INCREASE OF THE VOLUME OF THE HPV CONTROL IN CERVISTA HPV HR TEST AND LABELING CHANGES TO THE PACKAGE INSERT. |
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