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Items: 1 to 20 of 101

2.

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.

PMID:
23263896
3.
4.

FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.

Rome BN, Kramer DB, Kesselheim AS.

JAMA. 2014 Jan 22-29;311(4):385-91. doi: 10.1001/jama.2013.284986.

5.

High quality performance of pacemakers and implantable defibrillators.

Levine PA, Stanton MS, Sims JJ.

Pacing Clin Electrophysiol. 2002 Dec;25(12):1667-9. No abstract available.

PMID:
12520665
6.

First MRI-safe pacemaker receives conditional approval from FDA.

Mitka M.

JAMA. 2011 Mar 9;305(10):985-6. doi: 10.1001/jama.2011.273. No abstract available.

PMID:
21386073
7.

A protocol for patients with cardiovascular implantable devices undergoing magnetic resonance imaging (MRI): should defibrillation threshold testing be performed post-(MRI).

Burke PT, Ghanbari H, Alexander PB, Shaw MK, Daccarett M, Machado C.

J Interv Card Electrophysiol. 2010 Jun;28(1):59-66. doi: 10.1007/s10840-009-9463-y.

PMID:
20111895
8.

Opening the FDA black box.

Goodman SN, Redberg RF.

JAMA. 2014 Jan 22-29;311(4):361-3. doi: 10.1001/jama.2013.283946. No abstract available.

PMID:
24449313
9.

Quality of evidence behind FDA approvals varies widely.

McCarthy M.

BMJ. 2014 Jan 27;348:g1075. doi: 10.1136/bmj.g1075. No abstract available.

PMID:
24470635
10.

Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators.

Maisel WH, Sweeney MO, Stevenson WG, Ellison KE, Epstein LM.

JAMA. 2001 Aug 15;286(7):793-9.

PMID:
11497532
11.

Government viewpoint: U.S. Food & Drug Administration: Pacemakers, ICDs and MRI.

Faris OP, Shein MJ.

Pacing Clin Electrophysiol. 2005 Apr;28(4):268-9. No abstract available.

PMID:
15826256
12.

Please leave the reliable ICD leads alone.

Hauser RG.

Heart Rhythm. 2013 Apr;10(4):562-3. doi: 10.1016/j.hrthm.2012.12.024. No abstract available.

PMID:
23274369
14.

"MR-conditional" pacemakers: the radiologist's role in multidisciplinary management.

Colletti PM, Shinbane JS, Shellock FG.

AJR Am J Roentgenol. 2011 Sep;197(3):W457-9. doi: 10.2214/AJR.11.7120. Erratum in: AJR Am J Roentgenol. 2011 Oct;197(4):1024.

PMID:
21862773
15.

[MRI compatible cardiac pacemakers and implantable cardioverter defibrillators].

Šnorek M, Bulava A.

Vnitr Lek. 2014 Feb;60(2):123-7. Czech.

PMID:
24754416
16.

Safety of magnetic resonance imaging in patients with implanted cardiac prostheses and metallic cardiovascular electronic devices.

Baikoussis NG, Apostolakis E, Papakonstantinou NA, Sarantitis I, Dougenis D.

Ann Thorac Surg. 2011 Jun;91(6):2006-11. doi: 10.1016/j.athoracsur.2011.02.068. Review.

PMID:
21531377
17.

[Discrepancy between clinical data and approval documents].

Mellert F, Sinning JM.

Dtsch Med Wochenschr. 2015 Aug;140(17):1254. doi: 10.1055/s-0041-103139. German.

PMID:
26306009
18.

Current clinical issues for MRI scanning of pacemaker and defibrillator patients.

Kalin R, Stanton MS.

Pacing Clin Electrophysiol. 2005 Apr;28(4):326-8. Review.

PMID:
15826268
19.

Permanently implantable diagnostic computerized devices: where is the regulatory rar?

Krucoff MW.

J Electrocardiol. 2004;37 Suppl:68-70. No abstract available.

PMID:
15534804
20.

Safety of MRIs in patients with pacemakers and defibrillators.

Kodali S, Baher A, Shah D.

Methodist Debakey Cardiovasc J. 2013 Jul-Sep;9(3):137-41. Review.

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