Medical Device Regulatory Landscape-Reference-Cited by-同舟云学术

Medical Device Regulatory Landscape

Published:2012-02 Issue:1 Volume:5 Page:2-5
ISSN:1941-7640
Container-title:Circulation: Cardiovascular Interventions
language:en
Short-container-title:Circ: Cardiovascular Interventions

Author:

Kaplan Aaron V.¹,Williams David O.¹

Affiliation:

1. From the Section of Cardiology, Dartmouth-Hitchcock Medical Center, Dartmouth Medical School, Lebanon, NH (A.V.K.); and the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.O.W.).

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine

Link

https://www.ahajournals.org/doi/pdf/10.1161/CIRCINTERVENTIONS.112.968560

Reference8 articles.

1. US Food and Drug Administration Web Site. Medtronic recalls Sprint Fidelis Cardiac leads: questions and answers for consumers . http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm103022.htm. Accessed January 1 2012.

2. FDA approves first artificial aortic heart valve placed without open-heart surgery 2011 US Food and Drug Administration

3. Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery

4. Medical Device Development

5. Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical equipment (AIMDD). European Commission . http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction_notifiedbody.main. Accessed January 1 2012.

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