If your email program has trouble displaying this email, view as a webpage. | | August 27, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on August 26, 2021. To view listings for other dates, see CDRH New - News and Updates. - New Emergency Use Authorization
- Updated Emergency Use Authorization
- Meeting Notice: October 20, 2021 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
- Meeting Notice: November 2-3, 2021 Circulatory System Devices Panel of the Medical Devices Advisory Committee
- Mammography Problems at Madison Avenue Radiology Center 190th Broadway in New York, New York: FDA Safety Communication
- Consumer Information on: Guardant360 CDx – P200010/S002
- Consumer Information on: ASSURE Wearable Cardioverter Defibrillator System Kit (P/N 80014-001), Monitor (P/N 80008-003), Therapy Cable (P/N 80004-003), Garment Style A (P/N 80015-XXX*) and Style B (P/N 80016-XXX*), Rechargeable Battery (P/N 3322882-005), Carry Pack (3326503-003), Battery Charger (3326633-004), Tablet (P/N 80041-001) – P200037
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