Medtech approvals: FDA releases November 2016 PMA approvals

Summary of PMA Originals & Supplements Approved

• Originals: 1
• Supplements: 114

Submission Number	Date Final Decision	Review Track	Trade Name	Appl/Spr Name	Approval Order Statement
P150043	11/09/2016	PMAO – PMA Original	QVCAD SYSTEM	QVIEW MEDICAL, INC.	Approval for the QVCAD System. The QVCAD System is indicated for use as an aid to the reader during screening procedures in searching images of female breasts produced by the somo.v Automated Breast Ultrasound System (screening mammography BI- RADS® Assessment Category 1 or 2, and BI-RADS Composition/Density c or d) to detect mammography-occult lesions in regions not known to have suspicious findings. The indicators produced by the QVCAD System are not intended to be used for diagnostic characterization of suspicious findings.

The FDA also released a full list of supplement PMA approvals for the month.

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