CERVISTA HPV HR

Kit, Dna Detection, Human Papillomavirus

FDA Premarket Approval P080014 S005

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

Approval for the increase of the volume of the hpv control in cervista hpv hr test and labeling changes to the package insert.

DeviceCERVISTA HPV HR
Classification NameKit, Dna Detection, Human Papillomavirus
Generic NameKit, Dna Detection, Human Papillomavirus
ApplicantHOLOGIC, INC.
Date Received2010-10-21
Decision Date2011-03-29
PMAP080014
SupplementS005
Product CodeMAQ
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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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