PMA P110006S005

Device: INVENIA ABUS- AUTOMATED BREAST ULTRASOUND SYSTEM
Applicant: GE Healthcare
PMA number: P110006
Supplement: S005
Product code: PAA
Decision date: 2015-04-13
Classification: Automated Breast Ultrasound
Generic name: Automated breast ultrasound
Approval order statement: APPROVAL FOR A CHANGE IN APPLICATIONS TRAINING PROGRAM FOR THE INVENIA ABUS AUTOMATED BREAST ULTRASOUND SYSTEM. TWO ADDITIONAL TRAINING PROGRAMS WERE PROPOSED. THE FIRST ADDITION CONSISTS OF A ONE-DAY TRAINING PROGRAM FOR ONE TECHNOLOGIST/SCAN OPERATOR, EQUIVALENT TO THE PREVIOUSLY-APPROVED THREE-DAY PROGRAM FOR THREE TECHNOLOGISTS/SCAN OPERATORS. THE SECOND ADDITION CONSISTS OF A ONE-DAY TRAINING PROGRAM FOR A DESIGNATED SITEOPERATIONS SPECIALIST WHO IS EXPERIENCED IN INVENIA ABUS BREAST EXAMS, AND IS QUALIFIED FOR THE TRAINING ACCORDING TO A SET OF SPECIFIED REQUIREMENTS OUTLINED BY THE SPONSOR.

Current openFDA PMA Record#

Device: INVENIA ABUS- AUTOMATED BREAST ULTRASOUND SYSTEM
Applicant: GE Healthcare
PMA number: P110006
Supplement: S005
Product code: PAA
Generic name: Automated breast ultrasound
Decision date: 2015-04-13
Decision code: APPR
Date received: 2015-02-27
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A CHANGE IN APPLICATIONS TRAINING PROGRAM FOR THE INVENIA ABUS AUTOMATED BREAST ULTRASOUND SYSTEM. TWO ADDITIONAL TRAINING PROGRAMS WERE PROPOSED. THE FIRST ADDITION CONSISTS OF A ONE-DAY TRAINING PROGRAM FOR ONE TECHNOLOGIST/SCAN OPERATOR, EQUIVALENT TO THE PREVIOUSLY-APPROVED THREE-DAY PROGRAM FOR THREE TECHNOLOGISTS/SCAN OPERATORS. THE SECOND ADDITION CONSISTS OF A ONE-DAY TRAINING PROGRAM FOR A DESIGNATED SITEOPERATIONS SPECIALIST WHO IS EXPERIENCED IN INVENIA ABUS BREAST EXAMS, AND IS QUALIFIED FOR THE TRAINING ACCORDING TO A SET OF SPECIFIED REQUIREMENTS OUTLINED BY THE SPONSOR.