PMA P110006S008
- Device
- Invenia ABUS Autoated Breast Ultrasound System
- Applicant
- GE Healthcare
- PMA number
- P110006
- Supplement
- S008
- Product code
- PAA
- Decision date
- 2017-09-07
- Classification
- Automated Breast Ultrasound
- Generic name
- Automated breast ultrasound
- Approval order statement
- Approval for a manufacturing site change to GE Parallel Design Inc., 4313 E Cotton Center Blvd., Suite 100, Phoenix Arizona.
Current openFDA PMA Record#
- Device
- Invenia ABUS Autoated Breast Ultrasound System
- Applicant
- GE Healthcare
- PMA number
- P110006
- Supplement
- S008
- Product code
- PAA
- Generic name
- Automated breast ultrasound
- Decision date
- 2017-09-07
- Decision code
- APPR
- Date received
- 2017-02-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site change to GE Parallel Design Inc., 4313 E Cotton Center Blvd., Suite 100, Phoenix Arizona.