CERVISTA HPV 16/18

Kit, Dna Detection, Human Papillomavirus

FDA Premarket Approval P080015 S011

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.

Pre-market Approval Supplement Details

Increase of the manufacturing lot size for the cleavase enzyme solution using manual filling with gravimetric confirmation.

• Device: CERVISTA HPV 16/18
• Classification Name: Kit, Dna Detection, Human Papillomavirus
• Generic Name: Kit, Dna Detection, Human Papillomavirus
• Applicant: HOLOGIC, INC.
• Date Received: 2013-11-08
• Decision Date: 2013-12-03
• PMA: P080015
• Supplement: S011
• Product Code: MAQ
• Advisory Committee: Microbiology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: HOLOGIC, INC. 250 Campus Drive marlborough, MA 01752

Supplemental Filings

Supplement Number	Date	Supplement Type
P080015		Original Filing
S016	2018-10-16	30-day Notice
S015	2018-09-10	30-day Notice
S014	2018-08-31	30-day Notice
S013	2018-07-18	30-day Notice
S012	2015-04-30	30-day Notice
S011	2013-11-08	30-day Notice
S010	2013-08-02	Normal 180 Day Track No User Fee
S009	2013-07-31	Normal 180 Day Track No User Fee
S008	2012-06-11	30-day Notice
S007	2012-04-17	Real-time Process
S006	2012-01-09	Real-time Process
S005	2011-07-07	30-day Notice
S004	2011-06-02	30-day Notice
S003	2011-01-18	Real-time Process
S002	2010-11-29	Real-time Process
S001	2010-06-03	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
15420045500167	P080015	011