PMA P080014S019

Device: CERVISTA HPV HR TEST
Applicant: Hologic, Inc.
PMA number: P080014
Supplement: S019
Product code: MAQ
Decision date: 2014-03-04
Classification: Kit, Dna Detection, Human Papillomavirus
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
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.

Current openFDA PMA Record#

Device: CERVISTA HPV HR TEST
Applicant: Hologic, Inc.
PMA number: P080014
Supplement: S019
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 2014-03-04
Decision code: APPR
Date received: 2013-08-02
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
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.