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. |
|
Device | CERVISTA HPV 16/18 TEST |
Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
Applicant | HOLOGIC, INC. 250 Campus Drive Marlborough, MA 01752 |
PMA Number | P080015 |
Supplement Number | S010 |
Date Received | 08/02/2013 |
Decision Date | 03/04/2014 |
Withdrawal Date
|
04/19/2023 |
Product Code |
MAQ |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT GEN-PROBE INCORPORATED, SAN DIEGO, CALIFORNIA FOR THE MANUFACTURING OF THE CERVISTA HPV HR AND THE CERVISTA HPV 16/18. |
|
|