Cervista HPV 16/18 Assay

Kit, Dna Detection, Human Papillomavirus

FDA Premarket Approval P080015 S015

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

Transfer the purification and dilution operations for specified reagents within an existing manufacturing facility.

DeviceCervista HPV 16/18 Assay
Classification NameKit, Dna Detection, Human Papillomavirus
Generic NameKit, Dna Detection, Human Papillomavirus
ApplicantHOLOGIC, INC.
Date Received2018-09-10
Decision Date2018-10-09
PMAP080015
SupplementS015
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 01752

Supplemental Filings

Supplement NumberDateSupplement Type
P080015Original 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 IDPMASupp
15420045500167 P080015 011

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