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Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls
Kadakia, Kushal T, Dhruva, Sanket S, Caraballo, César, Ross, Joseph S, Krumholz, Harlan M
Published in JAMA : the journal of the American Medical Association (10.01.2023)
Published in JAMA : the journal of the American Medical Association (10.01.2023)
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Decompression and Coflex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis: two-year results from the prospective, randomized, multicenter, Food and Drug Administration Investigational Device Exemption trial
Davis, Reginald J, Errico, Thomas J, Bae, Hyun, Auerbach, Joshua D
Published in Spine (Philadelphia, Pa. 1976) (15.08.2013)
Published in Spine (Philadelphia, Pa. 1976) (15.08.2013)
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A new era of prospective real-world safety evaluation primary report of XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System condition-of-approval post-market study)
Krucoff, Mitchell W, Rutledge, David R, Gruberg, Luis, Jonnavithula, Lalitha, Katopodis, John N, Lombardi, William, Mao, Vivian W, Sharma, Samin K, Simonton, Charles A, Tamboli, Hoshedar P, Wang, Jin, Wilburn, Olivia, Zhao, Weiying, Sudhir, Krishnankutty, Hermiller, James B
Published in JACC. Cardiovascular interventions (01.12.2011)
Published in JACC. Cardiovascular interventions (01.12.2011)
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Current challenges for clinical trials of cardiovascular medical devices
Zannad, Faiez, Stough, Wendy Gattis, Piña, Ileana L., Mehran, Roxana, Abraham, William T., Anker, Stefan D., De Ferrari, Gaetano M., Farb, Andrew, Geller, Nancy L., Kieval, Robert S., Linde, Cecilia, Redberg, Rita F., Stein, Kenneth, Vincent, Alphons, Woehrle, Holger, Pocock, Stuart J.
Published in International journal of cardiology (15.07.2014)
Published in International journal of cardiology (15.07.2014)
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SCAI/ACC/HRS institutional and operator requirements for left atrial appendage occlusion
Kavinsky, Clifford J., Kusumoto, Fred M., Bavry, Anthony A., Bailey, Steven R., Ellenbogen, Kenneth A., Hess, Paul L., Lustgarten, Daniel L., Moussa, Issam D., Spies, Christian
Published in Heart rhythm (01.05.2016)
Published in Heart rhythm (01.05.2016)
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Interventional cardiology live case presentations: regulatory considerations
Farb, Andrew, Brown, Sheila A, Wolf, Deborah A, Zuckerman, Bram
Published in Journal of the American College of Cardiology (05.10.2010)
Published in Journal of the American College of Cardiology (05.10.2010)
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Interventional cardiology live case presentations: Regulatory considerations
Farb, Andrew, Brown, Sheila A., Wolf, Deborah A., Zuckerman, Bram
Published in Catheterization and cardiovascular interventions (01.10.2010)
Published in Catheterization and cardiovascular interventions (01.10.2010)
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Unique device identification system. Final rule
Published in Federal register
(24.09.2013)
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