SCOPUS 정보 검색 플랫폼

Circulation: Cardiovascular Interventions

Volumn 5, Issue 1, 2012, Pages 2-5

Medical device regulatory landscape the imperative of finding balance

(2) Kaplan, Aaron V a Williams, David O b

a DARTMOUTH MEDICAL SCHOOL (United States)

b HARVARD MEDICAL SCHOOL (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACUTE HEART INFARCTION; CARDIOVASCULAR EQUIPMENT; DEVICE SAFETY; EUROPE; HEALTH CARE SYSTEM; HEART VALVE; HEART VALVE REPLACEMENT; HUMAN; MEDICAL DEVICE; PERCUTANEOUS CORONARY INTERVENTION; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; TRANSCATHETER HEART VALVE; UNITED STATES;

ANIMALS; BIOTECHNOLOGY; CARDIOVASCULAR DISEASES; CLINICAL TRIALS AS TOPIC; DEVICE APPROVAL; EQUIPMENT AND SUPPLIES; EUROPE; GOVERNMENT REGULATION; HUMANS; PATENTS AS TOPIC; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84860851403 PISSN: 19417640 EISSN: 19417632 Source Type: Journal
DOI: 10.1161/CIRCINTERVENTIONS.112.968560 Document Type: Review

Times cited : (16)

References (8)

1
- 84860875174
- US Food and Drug Administration Web Site. Medtronic recalls Sprint Fidelis Cardiac leads: questions and answers for consumers Accessed January 1, 2012
- 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
- 84860853922
- US Food and Drug Administration. FDA approves first artificial aortic heart valve placed without open-heart surgery. November 2 2011 Accessed December 21, 2011
- US Food and Drug Administration. FDA approves first artificial aortic heart valve placed without open-heart surgery. November 2, 2011. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm278348. htm. Accessed December 21, 2011.

3
- 77958594295
- Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery
- for the PARTNER Trial Investigators
- Leon MB, Smith CR, Michael Mack MM, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG. Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; for the PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363: 1597-1607.
- (2010) N Engl J Med , vol.363 , pp. 1597-1607
- Leon, M.B.¹ Smith, C.R.² Michael Mack, M.M.³ Miller, D.C.⁴ Moses, J.W.⁵ Svensson, L.G.⁶ Tuzcu, E.M.⁷ Webb, J.G.⁸ Fontana, G.P.⁹ Makkar, R.R.¹⁰ Brown, D.L.¹¹ Block, P.C.¹² Guyton, R.A.¹³ Pichard, A.D.¹⁴ Bavaria, J.E.¹⁵ Herrmann, H.C.¹⁶ Douglas, P.S.¹⁷ Petersen, J.L.¹⁸ Akin, J.J.¹⁹ Anderson, W.N.²⁰ Wang, D.²¹ Pocock, S.²² more..

4
- 16544379129
- Medical device development: From prototype to regulatory approval
- Kaplan AV, Baim DS, Smith JJ, Feigal DA, Simons MS, Jefferys D, Fogarty TJ, Kuntz RE, Leon MB. Medical device development: from prototype to regulatory approval. Circulation. 2004;109:3068-3072.
- (2004) Circulation , vol.109 , pp. 3068-3072
- Kaplan, A.V.¹ Baim, D.S.² Smith, J.J.³ Feigal, D.A.⁴ Simons, M.S.⁵ Jefferys, D.⁶ Fogarty, T.J.⁷ Kuntz, R.E.⁸ Leon, M.B.⁹

5
- 84860865195
- 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 Accessed January 1, 2012
- 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.

6
- 84860875175
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (MDD); Council Directive 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices (IVDD) European Commission Accessed January 1, 2012
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (MDD); Council Directive 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices (IVDD). European Commission. http://www.emergogroup.com/ resources/articles/switching-notified-bodies. Accessed January 1, 2012.

7
- 84860846052
- Edwards Lifesciences receives CE Mark for Edwards SAPIEN Transcatheter Heart Valve September 5, Accessed January 15, 2012
- Edwards Lifesciences receives CE Mark for Edwards SAPIEN Transcatheter Heart Valve. September 5, 2007. http://www.edwards.com/fr/newsroom/Pages/ShowPR. aspx?PageGuid-{252fa581-d645-4c47-a20c-44e03fe6c8f3}. Accessed January 15, 2012.
- (2007)

8
- 84860853921
- Draft guidance for Industry and Food and Drug Administration Staff: the content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) applications for artificial pancreas device systems: draft guidance Accessed January
- Draft guidance for Industry and Food and Drug Administration Staff: the content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) applications for artificial pancreas device systems: draft guidance. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ ucm281706.htm. Accessed January 15, 2012.
- , vol.15 , pp. 2012

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.