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FDA PMA Number P080003, Selenia Dimensions/3Dimensions 3D System
FDA PMA Number P080003, Selenia Dimensions/3Dimensions 3D System
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$149.00 USD
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PMA Number: P080003
Device: Selenia Dimensions/3Dimensions 3D System
Generic Name: Digital breast tomosynthesis
Manufacturer: HOLOGIC, INC.
Product Code: OTE
Date Received: 09/15/2017
Decision Date: 03/23/2018
Notice Date: 01/00/1900
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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