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 HUMAN PAPILLOMA VIRUS (HPV) HIGH RISK (HR) |
Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
Applicant | HOLOGIC, INC. 250 CAMPUS DRIVE MARLBOROUGH, MA 01750 |
PMA Number | P080014 |
Supplement Number | S008 |
Date Received | 06/02/2011 |
Decision Date | 06/23/2011 |
Withdrawal Date
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04/19/2023 |
Product Code |
MAQ |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF A NEW SUPPLIER OF BOVINE SERUM ALBUMIN (BSA). |
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