title: Medical device regulatory reform: insights from the watchman left atrial appendage closure technology for stroke prophylaxis in atrial fibrillation.
authors: Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA.
authors: Eugenio
authors: E
authors: Cingolani
authors: Steven
authors: S
authors: Stevens
authors: Michael
authors: M
authors: Shehata
authors: George A
authors: GA
authors: Diamond
authors: Sanjay
authors: S
authors: Kaul
mesh_terms: D020517:Atrial Appendage / Q000601:surgery*; D001281:Atrial Fibrillation / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D006348:Cardiac Surgical Procedures / Q000295:instrumentation*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D018166:Health Care Reform / Q000379:methods*; D006801:Humans; D019736:Prostheses and Implants; D011474:Prosthesis Design; D020521:Stroke / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence