|
Device | CERVISTA HPV HR AND GENFIND KIT |
Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
Applicant | HOLOGIC, INC. 250 CAMPUS DRIVE MARLBOROUGH, MA 01750 |
PMA Number | P080014 |
Supplement Number | S018 |
Date Received | 07/31/2013 |
Decision Date | 04/29/2014 |
Withdrawal Date
|
04/19/2023 |
Product Code |
MAQ |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A POST APPROVAL STUDY LABELING UPDATE. |
Post-Approval Study | Show Report Schedule and Study Progress |