CERVISTA HUMAN PAPILLOMA VIRUS (HPV)

Kit, Dna Detection, Human Papillomavirus

FDA Premarket Approval P080014 S013

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

Change in the clinical development database software from version 5. 9 to version 6. 0.

DeviceCERVISTA HUMAN PAPILLOMA VIRUS (HPV)
Classification NameKit, Dna Detection, Human Papillomavirus
Generic NameKit, Dna Detection, Human Papillomavirus
ApplicantHOLOGIC, INC.
Date Received2012-06-11
Decision Date2012-07-03
PMAP080014
SupplementS013
Product CodeMAQ
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address HOLOGIC, INC. 250 Campus Drive marlborough, MA 01750

Supplemental Filings

Supplement NumberDateSupplement Type
P080014Original Filing
S024 2018-10-16 30-day Notice
S023 2018-09-10 30-day Notice
S022 2018-08-31 30-day Notice
S021 2018-07-18 30-day Notice
S020 2013-11-08 30-day Notice
S019 2013-08-02 Normal 180 Day Track No User Fee
S018 2013-07-31 Normal 180 Day Track No User Fee
S017 2013-07-24 30-day Notice
S016 2012-12-20 Real-time Process
S015 2012-12-19 Real-time Process
S014 2012-11-13 30-day Notice
S013 2012-06-11 30-day Notice
S012 2012-04-17 Real-time Process
S011 2012-01-09 Real-time Process
S010 2011-12-28 30-day Notice
S009 2011-07-07 30-day Notice
S008 2011-06-02 30-day Notice
S007 2011-04-27 Normal 180 Day Track
S006 2010-12-30 30-day Notice
S005 2010-10-21 Real-time Process
S004 2010-10-05 30-day Notice
S003 2010-09-16 Real-time Process
S002 2010-06-03 30-day Notice
S001 2009-06-24 30-day Notice

NIH GUDID Devices

Device IDPMASupp
15420045504271 P080014 019
15420045501065 P080014 020
15420045501058 P080014 020
15420045500969 P080014 020
15420045500952 P080014 020
15420045500150 P080014 020
15420045500143 P080014 020

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