INVENIA ABUS

Automated Breast Ultrasound

FDA Premarket Approval P110006 S002

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 change in the labeling materials (revised scan station user¿s manual, workstation user¿s manual, and user training program, as well as new patient positioning guide, quick reference guide ¿ positioning, product datasheet, and basic service manual).

• Device: INVENIA ABUS
• Classification Name: Automated Breast Ultrasound
• Generic Name: Automated Breast Ultrasound
• Applicant: U-SYSTEMS, INC.
• Date Received: 2014-01-17
• Decision Date: 2014-02-11
• PMA: P110006
• Supplement: S002
• Product Code: PAA
• Advisory Committee: Radiology
• Supplement Type: Real-time Process
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: U-SYSTEMS, INC. 9900 West Innovative Drive mail Stop Rp2138 wauwatosa, WI 53226

Supplemental Filings

Supplement Number	Date	Supplement Type
P110006		Original Filing
S010	2017-11-29	Normal 180 Day Track No User Fee
S009	2017-11-28	Normal 180 Day Track
S008	2017-02-28	Normal 180 Day Track No User Fee
S007	2016-08-03	Normal 180 Day Track
S006	2015-09-18	30-day Notice
S005	2015-02-27	Real-time Process
S004	2014-11-03	Real-time Process
S003	2014-02-26	30-day Notice
S002	2014-01-17	Real-time Process
S001	2013-03-07	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00840682100038	P110006	001
00840682100021	P110006	001
00840682100014	P110006	001
00840682100090	P110006	004
00840682141161	P110006	009
00195278756237	P110006	011
00195278756138	P110006	011