Progensa PCA3 Assay

FDA Premarket Approval P100033 S011

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

Manufacturing scale-up for reagents

DeviceProgensa PCA3 Assay
Generic NameProstrate Cancer Genes Nucleic Acid Amplification Test System
ApplicantGEN-PROBE INCORPORATED
Date Received2020-05-14
Decision Date2020-06-08
PMAP100033
SupplementS011
Product CodeOYM 
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address GEN-PROBE INCORPORATED 10210 Genetic Center Drive san Diego, CA 92121

Supplemental Filings

Supplement NumberDateSupplement Type
P100033Original Filing
S011 2020-05-14 30-day Notice
S010 2019-02-21 30-day Notice
S009 2018-09-25 30-day Notice
S008 2018-02-08 30-day Notice
S007 2017-10-10 30-day Notice
S006 2015-09-02 30-day Notice
S005 2015-06-12 30-day Notice
S004 2015-06-10 135 Review Track For 30-day Notice
S003 2015-03-19 30-day Notice
S002 2014-12-22 30-day Notice
S001 2013-11-20 30-day Notice

NIH GUDID Devices

Device IDPMASupp
25420045500775 P100033 001
15420045500747 P100033 001
15420045500754 P100033 001
15420045500761 P100033 001
15420045500785 P100033 001
15420045500792 P100033 001
15420045500808 P100033 001
15420045500815 P100033 001
25420045500775 P100033 001
15420045500730 P100033 001
15420045500747 P100033 001
15420045500754 P100033 001
15420045500761 P100033 001
15420045500785 P100033 001
15420045500792 P100033 001
15420045500808 P100033 001
15420045500815 P100033 001
15420045500730 P100033 001

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.