FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Automated Breast Ultrasound
PMA: P110006
·
Supplement: S003
·
Decision Mar 20, 2014
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Automated Breast Ultrasound
- Trade Name
- INVENIA ABUS
- PMA Number
- P110006
- Supplement Number
- S003
- Device Class
- FDA Class 3
- Product Code
- PAA
- Generic Name
- Automated breast ultrasound
- Medical Specialty
- Unknown
- Advisory Committee
- Radiology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- March 20, 2014
- Date Received
- February 26, 2014
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee 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.
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 |