Rhythmia Medical Fda Approval

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Summary APR 18 2013 - Food and Drug Administration

https://www.accessdata.fda.gov/cdrh_docs/pdf12/K122461.pdf

Food and Drug Administration 10903 New Hamrpshire Avenue Document Control Center -W066-G609 Apri 18,2013Silver Spring, MD 20993-0002-Rhythmia Medical, Inc. c/o Mr. Leon Amariglio Co-CEO I1I1 South Bedford Street, Suite 205 Burlington, MA 0 1803 Re: …

Boston Scientific Receives FDA 510(k) Clearance for the …

https://news.bostonscientific.com/2013-07-24-Boston-Scientific-Receives-FDA-510-k-Clearance-for-the-Rhythmia-Mapping-System

The Rhythmia Mapping System received CE Mark approval in May of 2013. Images of the Rhythmia Mapping System and IntellaMap Orion High Resolution Mapping …

November 27, 2019 - Food and Drug Administration

https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192438.pdf

enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic …

FDA 510(k) Clearance for the Rhythmia Mapping System

https://www.todaysmedicaldevelopments.com/news/fda-boston-scientific-rhythnia-medical-device-073013/

Boston Scientific Corp. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Rhythmia Mapping System, a next-generation 3D …

2020 Device Approvals | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/recently-approved-devices/2020-device-approvals

Jan 14, 2022

Approvals of FDA-Regulated Products | FDA - U.S. Food …

https://www.fda.gov/news-events/approvals-fda-regulated-products

Human drugs and therapeutic biologicals (proteins and other products derived from living sources used for therapeutic purposes) Drug Approval Reports by Month. Drugs@FDA. …

Boston Scientific to Acquire Rhythmia Medical, Inc.

https://news.bostonscientific.com/2012-10-08-Boston-Scientific-to-Acquire-Rhythmia-Medical-Inc.

Once the mapping system is cleared by the U.S. Food and Drug Administration and receives CE Mark approval in Europe, Boston Scientific expects to …

FDA clears Rhythmia Mapping System - Cardiac Rhythm News

https://cardiacrhythmnews.com/fda-clears-rhythmia-mapping-system/

24th July 2013. 2338. On 24 July, the US Food and Drug Administration (FDA) cleared Boston Scientific’s Rhythmia Mapping System, a next-generation 3D …

Boston Scientific launches its DirectSense technology in the USA

https://cardiacrhythmnews.com/boston-scientific-launches-its-directsense-technology-in-the-usa/

Boston Scientific has announced the US launch of DirectSense technology, a tool for monitoring the effect of radiofrequency (RF) energy delivery during cardiac …