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Items: 1 to 20 of 115

1.

Premarket assessment of devices for treatment of critical limb ischemia: the role of Objective Performance Criteria and Goals.

Geraghty PJ, Matsumura JS, Conte MS.

J Vasc Surg. 2009 Dec;50(6):1459-61. doi: 10.1016/j.jvs.2009.10.041. Epub 2009 Nov 7.

2.

FDA perspective on objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia.

Kumar A, Brooks SS, Cavanaugh K, Zuckerman B.

J Vasc Surg. 2009 Dec;50(6):1474-6. doi: 10.1016/j.jvs.2009.09.045. Epub 2009 Nov 7. Review.

3.

Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia.

Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, Nehler MR, Powell RJ, Sidawy AN.

J Vasc Surg. 2009 Dec;50(6):1462-73.e1-3. doi: 10.1016/j.jvs.2009.09.044. Epub 2009 Nov 7. Review.

4.

Understanding objective performance goals for critical limb ischemia trials.

Conte MS.

Semin Vasc Surg. 2010 Sep;23(3):129-37. doi: 10.1053/j.semvascsurg.2010.06.001. Review.

PMID:
20826289
5.

FDA marketing claims, and the practitioner.

Runner S.

J Evid Based Dent Pract. 2006 Mar;6(1):19-23.

PMID:
17138391
6.

The "art" of medicine and the "smokescreen" of the randomized trial off-label use of vascular devices.

Ansel GM, Jaff MR.

Catheter Cardiovasc Interv. 2008 Dec 1;72(7):998-1002. doi: 10.1002/ccd.21776.

PMID:
19021289
8.

FDA regulation of cardiovascular devices and opportunities for improvement.

Dhruva SS, Redberg RF.

J Interv Card Electrophysiol. 2013 Mar;36(2):99-105. doi: 10.1007/s10840-012-9767-1. Epub 2012 Dec 21.

PMID:
23263896
9.
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11.

The FDA process for the evaluation and approval of orthopaedic devices.

Kirkpatrick JS, Stevens T.

J Am Acad Orthop Surg. 2008 May;16(5):260-7. Review.

PMID:
18460686
12.

Food and Drug Administration regulation of in vitro diagnostic devices.

Mansfield E, O'Leary TJ, Gutman SI.

J Mol Diagn. 2005 Feb;7(1):2-7. Review.

13.

An overview of FDA medical device regulation as it relates to deep brain stimulation devices.

Peña C, Bowsher K, Costello A, De Luca R, Doll S, Li K, Schroeder M, Stevens T.

IEEE Trans Neural Syst Rehabil Eng. 2007 Sep;15(3):421-4. Review.

PMID:
17894274
14.

U.S. Food and Drug Administration and off-label use of expandable metal biliary stents within the peripheral vasculature.

Yustein AS, Schultz D, Neuland C, Buckles DS, Nipper JC, Stephenson RA, Gonzalez G.

J Vasc Interv Radiol. 2008 Jul;19(7):965-9. Review.

PMID:
18672491
15.

Regulatory approval of peripheral endovascular revascularization devices in the United States: is the horse still in the barn?

Weinberger J, Rundback JH, Ratchford EV.

Am J Ther. 2005 Mar-Apr;12(2):186-91. Review.

PMID:
15767839
16.

Cochlear implants: overview of safety and effectiveness. The FDA evaluation.

Yin L, Segerson DA.

Otolaryngol Clin North Am. 1986 May;19(2):423-33.

PMID:
3520445
17.

Medical device recall authority--FDA. Final rule.

[No authors listed]

Fed Regist. 1996 Nov 20;61(225):59004-22.

PMID:
10163116
18.

Prosthetic heart valves: Objective Performance Criteria versus randomized clinical trial.

Grunkemeier GL, Jin R, Starr A.

Ann Thorac Surg. 2006 Sep;82(3):776-80.

PMID:
16928482
19.

Overview of the 2007 Food and Drug Administration Circulatory System Devices Panel meeting on the Xience V Everolimus-Eluting Coronary Stent.

Torguson R, Waksman R.

Am J Cardiol. 2008 Dec 15;102(12):1624-30. doi: 10.1016/j.amjcard.2008.08.013. Epub 2008 Sep 24.

PMID:
19064016
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