INVENIA ABUS
FDA premarket approval P110006/S002 · decided 2014-02-11
Approval details
- PMA number
- P110006
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INVENIA ABUS
- Generic name
- Automated breast ultrasound
- Applicant
- GE Healthcare
- Date received
- 2014-01-17
- Decision date
- 2014-02-11
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- PAA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Wauwatosa, WI
- Statement
- APPROVAL FOR CHANGE IN THE LABELING MATERIALS (REVISED SCAN STATION USER¿S MANUAL, WORKSTATION USER¿S MANUAL, AND USER TRAINING PROGRAM, AS WELL AS NEW PATIENT POSITIONING GUIDE, QUICK REFERENCE GUIDE ¿ POSITIONING, PRODUCT DATASHEET, AND BASIC SERVICE MANUAL).
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