-
1
-
-
84870440930
-
-
Accessed December 26, 2013
-
Premarket approval (PMA). US Food and Drug Administration. http://www.fda.gov /medicaldevices/deviceregulationandguidance /howtomarketyourdevice/premarketsubmissions /premarketapprovalpma/. Accessed December 26, 2013.
-
Premarket Approval (PMA)
-
-
-
2
-
-
84892764839
-
-
Accessed December 26, 2013
-
Medical Device Amendments of 1976 [Pub L No. 94-295]. US Government Printing Office. http://www.gpo.gov/fdsys/pkg/STATUTE-90/pdf /STATUTE-90-Pg539.pdf. Accessed December 26, 2013.
-
Medical Device Amendments of 1976 [Pub L No. 94-295]
-
-
-
3
-
-
57749094854
-
Learning from our mistakes? Testing new ICD technology
-
Hauser RG, Almquist AK. Learning from our mistakes? testing new ICD technology. N Engl J Med. 2008;359(24):2517-2519.
-
(2008)
N Engl J Med
, vol.359
, Issue.24
, pp. 2517-2519
-
-
Hauser, R.G.1
Almquist, A.K.2
-
4
-
-
84861997198
-
An ICD lead advisory: A plea for more diligence and more data
-
Kay GN, Ellenbogen KA. An ICD lead advisory: a plea for more diligence and more data. Pacing Clin Electrophysiol. 2012;35(6):648-649.
-
(2012)
Pacing Clin Electrophysiol
, vol.35
, Issue.6
, pp. 648-649
-
-
Kay, G.N.1
Ellenbogen, K.A.2
-
5
-
-
84892710404
-
-
Accessed January 4, 2013
-
Premarket approval (PMA) database. US Food and Drug Administration. http://www.accessdata\.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm. Accessed January 4, 2013.
-
Premarket Approval (PMA) Database
-
-
-
7
-
-
84892753379
-
-
US Dept of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research. Accessed December 26, 2013
-
Guidance for industry and FDA staff: modifications to devices subject to premarket approval (PMA): the PMA supplement decision-making process [2008]. US Dept of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research. http://www.fda.gov/downloads /MedicalDevices/DeviceRegulationandGuidance /GuidanceDocuments/UCM089360.pdf. Accessed December 26, 2013.
-
(2008)
Guidance for Industry and FDA Staff: Modifications to Devices Subject to Premarket Approval (PMA): The PMA Supplement Decision-making Process
-
-
-
8
-
-
84878988379
-
-
US Dept of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Center for Biologics Evaluation and Research. Accessed December 26, 2013
-
The least burdensome provisions of the FDA Modernization Act of 1997: concept and principles: final guidance for FDA and industry. US Dept of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Center for Biologics Evaluation and Research. http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance /GuidanceDocuments/ucm085994.htm. Accessed December 26, 2013.
-
The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles: Final Guidance for FDA and Industry
-
-
-
9
-
-
0242348703
-
Implantable cardioverter-defibrillators
-
DiMarco JP. Implantable cardioverter-defibrillators. N Engl J Med. 2003;349(19):1836-1847.
-
(2003)
N Engl J Med
, vol.349
, Issue.19
, pp. 1836-1847
-
-
DiMarco, J.P.1
-
10
-
-
84892711852
-
-
Accessed January 20, 2013
-
Product classification. US Food and Drug Administration. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm. Accessed January 20, 2013.
-
Product Classification
-
-
-
11
-
-
84892719702
-
-
Accessed December 26, 2013
-
Safe Medical Devices Act of 1990 [Pub L No. 101-629]. US Government Printing Office. http://www.gpo.gov/fdsys/pkg/STATUTE-104/pdf/STATUTE-104- Pg4511.pdf. Accessed December 26, 2013.
-
Safe Medical Devices Act of 1990 [Pub L No. 101-629]
-
-
-
14
-
-
84901296331
-
-
Accessed October 26, 2013
-
PMA review fees. US Food and Drug Administration. http://www.fda.gov /MedicalDevices/DeviceRegulationandGuidance /HowtoMarketYourDevice/ PremarketSubmissions /PremarketApprovalPMA/ucm048161.htm. Accessed October 26, 2013.
-
PMA Review Fees
-
-
-
16
-
-
73949084847
-
Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices
-
Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA. 2009;302(24):2679-2685.
-
(2009)
JAMA
, vol.302
, Issue.24
, pp. 2679-2685
-
-
Dhruva, S.S.1
Bero, L.A.2
Redberg, R.F.3
-
17
-
-
76149099323
-
Premarket clinical evaluation of novel cardiovascular devices: Quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007
-
Kramer DB, Mallis E, Zuckerman BD, Zimmerman BA, Maisel WH. Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007. Am J Ther. 2010;17(1):2-7.
-
(2010)
Am J Ther
, vol.17
, Issue.1
, pp. 2-7
-
-
Kramer, D.B.1
Mallis, E.2
Zuckerman, B.D.3
Zimmerman, B.A.4
Maisel, W.H.5
-
18
-
-
84868313703
-
Inclusion of comparative effectiveness data in high-risk cardiovascular device studies at the time of premarket approval
-
Chen CE, Dhruva SS, Redberg RF. Inclusion of comparative effectiveness data in high-risk cardiovascular device studies at the time of premarket approval. JAMA. 2012;308(17):1740-1742.
-
(2012)
JAMA
, vol.308
, Issue.17
, pp. 1740-1742
-
-
Chen, C.E.1
Dhruva, S.S.2
Redberg, R.F.3
-
19
-
-
57749107620
-
Testing new ICD technology
-
Shein MJ, Schultz DG. Testing new ICD technology. N Engl J Med. 2008;359(24):2610.
-
(2008)
N Engl J Med
, vol.359
, Issue.24
, pp. 2610
-
-
Shein, M.J.1
Schultz, D.G.2
-
20
-
-
84880055964
-
Variation among hospitals in selection of higher-cost, "higher-tech," implantable cardioverter-defibrillators: Data from the National Cardiovascular Data Registry (NCDR) Implantable Cardioverter/ Defibrillator (ICD) Registry
-
Lampert R,Wang Y, Curtis JP. Variation among hospitals in selection of higher-cost, "higher-tech," implantable cardioverter-defibrillators: data from the National Cardiovascular Data Registry (NCDR) Implantable Cardioverter/Defibrillator (ICD) Registry. Am Heart J. 2013;165(6):1015-1023.
-
(2013)
Am Heart J
, vol.165
, Issue.6
, pp. 1015-1023
-
-
Lampert, R.1
Wang, Y.2
Curtis, J.P.3
-
21
-
-
84892773107
-
-
Accessed December 27, 2013
-
Premarket approval (PMA) database: 2012;S176:010031. US Food and Drug Administration. http://www.accessdata.fda.gov /scripts/cdrh/cfdocs/cfpma/pma. cfm?id=26238. Accessed December 27, 2013.
-
(2012)
Premarket Approval (PMA) Database
, vol.S176
, pp. 010031
-
-
-
23
-
-
79955726540
-
Medical device recalls and the FDA approval process
-
Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch Intern Med. 2011;171(11):1006-1011.
-
(2011)
Arch Intern Med
, vol.171
, Issue.11
, pp. 1006-1011
-
-
Zuckerman, D.M.1
Brown, P.2
Nissen, S.E.3
-
24
-
-
84872082045
-
The 510(k) ancestry of ametal-on-metal hip implant
-
Ardaugh BM, Graves SE, Redberg RF. The 510(k) ancestry of ametal-on-metal hip implant. N Engl J Med. 2013;368(2):97-100.
-
(2013)
N Engl J Med
, vol.368
, Issue.2
, pp. 97-100
-
-
Ardaugh, B.M.1
Graves, S.E.2
Redberg, R.F.3
-
25
-
-
84886900749
-
HHS. Unique device identification system: Final rule
-
Food and Drug Administration
-
Food and Drug Administration, HHS. Unique device identification system: final rule. Fed Regist. 2013;78(185):58785-58828.
-
(2013)
Fed Regist
, vol.78
, Issue.185
, pp. 58785-58828
-
-
|