Aptima HCV RNA Qualitative Assay

FDA Premarket Approval P020011 S016

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

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DeviceAptima HCV RNA Qualitative Assay
Generic NameAssay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
ApplicantGEN-PROBE
Date Received2020-07-09
Decision Date2020-07-21
PMAP020011
SupplementS016
Product CodeMZP 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address GEN-PROBE 10210 Genetic Center Dr. san Diego, CA 92121

Supplemental Filings

Supplement NumberDateSupplement Type
P020011Original Filing
S016 2020-07-09 30-day Notice
S015 2020-02-12 30-day Notice
S014 2019-05-21 30-day Notice
S013 2019-03-27 30-day Notice
S012 2019-02-21 30-day Notice
S011 2018-10-02 30-day Notice
S010 2017-10-10 30-day Notice
S009 2015-09-04 135 Review Track For 30-day Notice
S008 2015-04-10 30-day Notice
S007 2013-03-13 30-day Notice
S006 2012-12-18 30-day Notice
S005 2012-04-05 Normal 180 Day Track No User Fee
S004 2010-08-23 30-day Notice
S003 2010-03-31 30-day Notice
S002 2010-02-23 135 Review Track For 30-day Notice
S001 2009-05-01 30-day Notice

NIH GUDID Devices

Device IDPMASupp
15420045500235 P020011 007
15420045500228 P020011 007
15420045500211 P020011 007
15420045500235 P020011 007
15420045500228 P020011 007
15420045500211 P020011 007

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