PMA P110006S002

Device: INVENIA ABUS
Applicant: GE Healthcare
PMA number: P110006
Supplement: S002
Product code: PAA
Decision date: 2014-02-11
Classification: Automated Breast Ultrasound
Generic name: Automated breast ultrasound
Approval order statement: 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).

Current openFDA PMA Record#

Device: INVENIA ABUS
Applicant: GE Healthcare
PMA number: P110006
Supplement: S002
Product code: PAA
Generic name: Automated breast ultrasound
Decision date: 2014-02-11
Decision code: APPR
Date received: 2014-01-17
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: 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).