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FDA PMA Number P160031 S001, ASPIRE Cristalle Breast Tomosynthesis System
FDA PMA Number P160031 S001, ASPIRE Cristalle Breast Tomosynthesis System
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Contents: PMA Supplement Application for PMA Number P160031, Supplement Number S001.
Request Year: 2023
PMA Number: P160031
Device: ASPIRE Cristalle Breast Tomosynthesis System
Generic Name: Digital breast tomosynthesis
Manufacturer: FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Product Code: OTE
Date Received: 10/23/2018
Decision Date: 02/08/2019
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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