PMA P110006S007
- Device
- Invenia ABUS - Automated Breast Ultrasound System
- Applicant
- GE Healthcare
- PMA number
- P110006
- Supplement
- S007
- Product code
- PAA
- Decision date
- 2017-05-01
- Classification
- Automated Breast Ultrasound
- Generic name
- Automated breast ultrasound
- Approval order statement
- Approval for a change to the labeling to allow the use of ultrasound gel in addition to currently required ultrasound lotion with the system
Current openFDA PMA Record#
- Device
- Invenia ABUS - Automated Breast Ultrasound System
- Applicant
- GE Healthcare
- PMA number
- P110006
- Supplement
- S007
- Product code
- PAA
- Generic name
- Automated breast ultrasound
- Decision date
- 2017-05-01
- Decision code
- APPR
- Date received
- 2016-08-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to the labeling to allow the use of ultrasound gel in addition to currently required ultrasound lotion with the system