PMA P110006S006

Device: INVENIA ABUS -- AUTOMATED BREAST ULTRASOUND SYSTEM
Applicant: GE Healthcare
PMA number: P110006
Supplement: S006
Product code: PAA
Decision date: 2015-10-15
Classification: Automated Breast Ultrasound
Generic name: Automated breast ultrasound
Approval order statement: CHANGES IN SUPPLIERS FOR 12 CRITICAL PARTS, TO IMPROVE THE PARTS' QUALITY, PRODUCTIVITY, AND DELIVERY. THE COMMON CHARACTERISTIC OF ALL 12 PARTS IS THEIR ELECTRICAL CONDUCTIVITY ON SPECIFIED SURFACES, TO ALLOW ELECTRICAL CONTINUITY FOR PROPER GROUNDING OF YOUR DEVICE. THE PROPOSED CHANGES DO NOT INVOLVE ANY CHANGES IN THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE.

Current openFDA PMA Record#

Device: INVENIA ABUS -- AUTOMATED BREAST ULTRASOUND SYSTEM
Applicant: GE Healthcare
PMA number: P110006
Supplement: S006
Product code: PAA
Generic name: Automated breast ultrasound
Decision date: 2015-10-15
Decision code: OK30
Date received: 2015-09-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES IN SUPPLIERS FOR 12 CRITICAL PARTS, TO IMPROVE THE PARTS' QUALITY, PRODUCTIVITY, AND DELIVERY. THE COMMON CHARACTERISTIC OF ALL 12 PARTS IS THEIR ELECTRICAL CONDUCTIVITY ON SPECIFIED SURFACES, TO ALLOW ELECTRICAL CONTINUITY FOR PROPER GROUNDING OF YOUR DEVICE. THE PROPOSED CHANGES DO NOT INVOLVE ANY CHANGES IN THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE.