FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Automated Breast Ultrasound
PMA: P110006
·
Supplement: S007
·
Decision May 1, 2017
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Automated Breast Ultrasound
- Trade Name
- Invenia ABUS - Automated Breast Ultrasound System
- PMA Number
- P110006
- Supplement Number
- S007
- Device Class
- FDA Class 3
- Product Code
- PAA
- Generic Name
- Automated breast ultrasound
- Medical Specialty
- Unknown
- Advisory Committee
- Radiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 1, 2017
- Date Received
- August 3, 2016
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PAA | Automated Breast Ultrasound | FDA class 3 | Unknown |