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Volumn 160, Issue 11, 2014, Pages 798-799

Premarket approval supplement pathway: Do we know what we are getting?

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL STUDY; COCHLEA PROSTHESIS; DEFIBRILLATOR; DEVICE APPROVAL; DEVICE SAFETY; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HEALTH HAZARD; HUMAN; INFUSION PUMP; KNEE ARTHROPLASTY; MEDICAL DEVICE; NOTE; PHYSICIAN; POLICY; PRIORITY JOURNAL; PROSTHESIS FAILURE; REGISTER; RISK BENEFIT ANALYSIS; UNCERTAINTY;

EID: 84901791244     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/M13-2931     Document Type: Note
Times cited : (14)

References (7)
  • 1
    • 84901810096 scopus 로고    scopus 로고
    • MarketsandMarkets. Report MD 1620. Pune, India: MarketsandMarkets
    • MarketsandMarkets. Global Top 10 Medical Devices Market (2010-2015). Report MD 1620. Pune, India: MarketsandMarkets; 2011.
    • (2011) Global Top 10 Medical Devices Market (2010-2015)
  • 2
    • 84901292319 scopus 로고    scopus 로고
    • Silver Spring, MD: U.S. Food and Drug Administration; Accessed at on 3 September 2013
    • U.S. Food and Drug Administration. Premarket Approval (PMA). Silver Spring, MD: U.S. Food and Drug Administration; 2012. Accessed at www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/ premarketsubmissions/premarketapprovalpma on 3 September 2013.
    • (2012) Premarket Approval (PMA)
  • 3
    • 84901796734 scopus 로고    scopus 로고
    • Silver Spring, MD: U.S. Food and Drug Administration; Accessed at on 3 September 2013
    • U.S. Food and Drug Administration. PMA Supplements and Amendments. Silver Spring, MD: U.S. Food and Drug Administration; 2010. Accessed at www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarket YourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm050467.htm on 3 September 2013.
    • (2010) PMA Supplements and Amendments
  • 4
    • 64649087022 scopus 로고    scopus 로고
    • Increasing hazard of Sprint Fidelis implantable cardioverter- defibrillator lead failure
    • PMID: 19285920
    • Hauser RG, Hayes DL. Increasing hazard of Sprint Fidelis implantable cardioverter-defibrillator lead failure. Heart Rhythm. 2009;6:605-10. [PMID: 19285920]
    • (2009) Heart Rhythm , vol.6 , pp. 605-610
    • Hauser, R.G.1    Hayes, D.L.2
  • 5
    • 40449140715 scopus 로고    scopus 로고
    • Semper Fidelis - Consumer protection for patients with implanted medical devices
    • DOI 10.1056/NEJMp0800495
    • Maisel WH. Semper fidelis - consumer protection for patients with implanted medical devices. N Engl J Med. 2008;358:985-7. [PMID: 18322280] (Pubitemid 351347096)
    • (2008) New England Journal of Medicine , vol.358 , Issue.10 , pp. 985-987
    • Maisel, W.H.1
  • 6
    • 77955713825 scopus 로고    scopus 로고
    • Multicenter experience with extraction of the Sprint Fidelis implantable cardioverter-defibrillator lead
    • PMID: 20598467
    • Maytin M, Love CJ, Fischer A, Carrillo RG, Garisto JD, Bongiorni MG, et al. Multicenter experience with extraction of the Sprint Fidelis implantable cardioverter-defibrillator lead. J Am Coll Cardiol. 2010;56:646-50. [PMID: 20598467]
    • (2010) J Am Coll Cardiol , vol.56 , pp. 646-650
    • Maytin, M.1    Love, C.J.2    Fischer, A.3    Carrillo, R.G.4    Garisto, J.D.5    Bongiorni, M.G.6
  • 7
    • 84875308072 scopus 로고    scopus 로고
    • Independent multicenter study of Riata and Riata ST implantable cardioverter-defibrillator leads
    • PMID: 23128017
    • Abdelhadi RH, Saba SF, Ellis CR, Mason PK, Kramer DB, Friedman PA, et al. Independent multicenter study of Riata and Riata ST implantable cardioverter-defibrillator leads. Heart Rhythm. 2013;10:361-5. [PMID: 23128017]
    • (2013) Heart Rhythm , vol.10 , pp. 361-365
    • Abdelhadi, R.H.1    Saba, S.F.2    Ellis, C.R.3    Mason, P.K.4    Kramer, D.B.5    Friedman, P.A.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.