Rapid fFN for the TLilQ System

FDA Premarket Approval P920048 S020

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

Addition of a manufacturing site at 10210 genetic center dr. , san diego, ca 92121 (gcd) for the manufacture of critical components of the rapid ffn for the tliiq system, namely the control kit, calibrators and other internal use-only components

DeviceRapid fFN for the TLilQ System
Generic NameEnzyme Immunoassay, Fetal Fibronectin
ApplicantHOLOGIC, INC.
Date Received2021-04-09
Decision Date2021-04-29
PMAP920048
SupplementS020
Product CodeLKV 
Advisory CommitteeToxicology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address HOLOGIC, INC. 1240 Elko Drive sunnyvale, CA 94089

Supplemental Filings

Supplement NumberDateSupplement Type
P920048Original Filing
S020 2021-04-09 30-day Notice
S019
S018 2020-09-08 30-day Notice
S017 2020-07-10 30-day Notice
S016
S015
S014 2018-11-20 30-day Notice
S013
S012
S011 2015-06-10 Real-time Process
S010
S009 2015-04-09 Real-time Process
S008 2014-06-24 30-day Notice
S007
S006 2008-09-29 30-day Notice
S005 2007-12-21 Normal 180 Day Track No User Fee
S004
S003 2000-09-11 Normal 180 Day Track
S002 1998-02-13 Normal 180 Day Track
S001 1996-06-26 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
15420045500884 P920048 006
15420045500877 P920048 006
15420045501171 P920048 008
15420045501164 P920048 008
15420045505346 P920048 009

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