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 16/18 |
Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
Applicant | HOLOGIC, INC. 250 Campus Drive Marlborough, MA 01752 |
PMA Number | P080015 |
Supplement Number | S005 |
Date Received | 07/07/2011 |
Decision Date | 08/02/2011 |
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 CHANGE IN THE STATISTICAL METHOD EMPLOYED DURING INCOMING MATERIAL INSPECTION OF THE HPV CONTROLS OF THE CERVISTA® HPV 16/18 AND REAGENTS IN THE GENFIND® DNA EXTRACTION KIT. |
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