PMA P110006S003
- Device
- INVENIA ABUS
- Applicant
- GE Healthcare
- PMA number
- P110006
- Supplement
- S003
- Product code
- PAA
- Decision date
- 2014-03-20
- Classification
- Automated Breast Ultrasound
- Generic name
- Automated breast ultrasound
- Approval order statement
- CHANGES TO INCLUDE UPDATING MANUFACTURING DOCUMENTS, WORK INSTRUCTIONS, AND TEST PROCEDURES. ALSO, HIGH LEVEL ASSEMBLY OF SOME SUBCOMPONENTS WILL BE PERFORMED BY PLEXUS CORPORATION.
Current openFDA PMA Record#
- Device
- INVENIA ABUS
- Applicant
- GE Healthcare
- PMA number
- P110006
- Supplement
- S003
- Product code
- PAA
- Generic name
- Automated breast ultrasound
- Decision date
- 2014-03-20
- Decision code
- OK30
- Date received
- 2014-02-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO INCLUDE UPDATING MANUFACTURING DOCUMENTS, WORK INSTRUCTIONS, AND TEST PROCEDURES. ALSO, HIGH LEVEL ASSEMBLY OF SOME SUBCOMPONENTS WILL BE PERFORMED BY PLEXUS CORPORATION.