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An integrated benefit-risk assessment of cobalt-containing alloys used in medical devices: Implications for regulatory requirements in the European Union.
Eichenbaum, Gary; Wilsey, Jared T; Fessel, Gion; Qiu, Qing-Qing; Perkins, Laura; Hasgall, Philippe; Monnot, Andrew; More, Sharlee L; Egnot, Natalie; Sague, Jorge; Marcello, Stephen; Connor, Kevin; Scutti, James; Christian, Whitney V; Coplan, Paul M; Wright, John; Hastings, Bob; Katz, Laurence B; Vreeke, Mark; Calistri-Yeh, Millie; Faiola, Brenda; Purushothaman, Bushan; Nevelos, Jim; Bashiri, Mehran; Christensen, Jesper Bjerg; Kovochich, Michael; Unice, Kenneth.
Afiliação
  • Eichenbaum G; Johnson & Johnson, 410 George St, New Brunswick, NJ, 08901, USA.
  • Wilsey JT; Smith & Nephew, 1450 E Brooks Rd, Memphis, TN, 38116, USA.
  • Fessel G; Smith & Nephew, Oberneuhofstasse 10D, 6340, Baar, Switzerland.
  • Qiu QQ; Stryker, 2825 Airview Boulevard, Kalamazoo, MI, 49002, USA.
  • Perkins L; Abbott Vascular, 3200 Lakeside Dr, Santa Clara, CA, 95054, USA.
  • Hasgall P; Zimmer Biomet, Sulzerallee 8, CH-8404 Winterthur, Switzerland.
  • Monnot A; Cardno ChemRisk, 235 Pine Street Suite 2300, San Francisco, CA, 94104, USA.
  • More SL; Cardno ChemRisk, 6720 S Macadam Ave Suite 150, Portland, OR, 97219, USA.
  • Egnot N; Cardno ChemRisk, 20 Stanwix Street Suite 505, Pittsburgh, PA, 15222, USA.
  • Sague J; Stryker, 2825 Airview Boulevard, Kalamazoo, MI, 49002, USA.
  • Marcello S; Ethicon, A J&J Company, Cincinnati, OH, 45242, USA.
  • Connor K; Boston Scientific, 100 Boston Scientific Way, Marlborough, MA, 01752, USA.
  • Scutti J; Boston Scientific, 100 Boston Scientific Way, Marlborough, MA, 01752, USA.
  • Christian WV; Medtronic Plc, 6743 Southpoint Drive North, Jacksonville, FL, 32216, USA.
  • Coplan PM; Johnson & Johnson, 410 George St, New Brunswick, NJ, 08901, USA; University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, 19104, USA.
  • Wright J; Johnson & Johnson, 410 George St, New Brunswick, NJ, 08901, USA.
  • Hastings B; Johnson & Johnson, 410 George St, New Brunswick, NJ, 08901, USA.
  • Katz LB; LifeScan Global Corporation, 20 Valley Stream Parkway, Malvern, PA, 19355, USA.
  • Vreeke M; Edwards Lifesciences, One Edwards Way, Irvine, CA, 92614, USA.
  • Calistri-Yeh M; Becton Dickinson, 1 Becton Drive, Franklin Lakes, NJ, 07417, USA.
  • Faiola B; Becton Dickinson, 1 Becton Drive, Franklin Lakes, NJ, 07417, USA; Rho, Inc., 2635 E NC Hwy 54, Durham, NC, 27713, USA.
  • Purushothaman B; Medtronic Plc, 8200 Coral Sea St NE, Mounds View, MN, 55112, USA.
  • Nevelos J; Stryker, 2825 Airview Boulevard, Kalamazoo, MI, 49002, USA.
  • Bashiri M; Stryker Neurovascular, 47900 Bayside Parkway, Fremont, CA, 94538, USA.
  • Christensen JB; Novo Nordisk A/S, Stenager Allé 4, 9800, Hjørring, Denmark.
  • Kovochich M; Cardno ChemRisk, 30 North LaSalle St Suite 3910, Chicago, Illinois, 60602-2590, USA.
  • Unice K; Cardno ChemRisk, 20 Stanwix Street Suite 505, Pittsburgh, PA, 15222, USA. Electronic address: Ken.Unice@cardno.com.
Regul Toxicol Pharmacol ; 125: 105004, 2021 Oct.
Article em En | MEDLINE | ID: mdl-34256083
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Cobalto / Equipamentos e Provisões / Ligas / Doenças Genitais / Neoplasias Tipo de estudo: Etiology_studies / Risk_factors_studies Limite: Humans Idioma: En Revista: Regul Toxicol Pharmacol Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Cobalto / Equipamentos e Provisões / Ligas / Doenças Genitais / Neoplasias Tipo de estudo: Etiology_studies / Risk_factors_studies Limite: Humans Idioma: En Revista: Regul Toxicol Pharmacol Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos