1. Food and Drug Administration. Introduction and Regulatory Reference Sheet. Circulatory Devices Advisory Panel December 5–6, 2012. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM330365.pdf. Accessed January 10, 2013.
2. Food and Drug Administration. 21 CFR 860.93 - Classification of Implants, Life Supporting or Life-Sustaining Devices. Available at: http://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol8/pdf/CFR-2011-title21-vol8-sec860-93.pdf. Accessed January 10, 2013.
3. Food and Drug Administration. Sec. 515; Sec. 360e - Premarket approval. http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapV-partA-sec360e.pdf. Accessed January 10, 2012.
4. Food and Drug Administration. Medical Devices; Order for Certain Class III Devices; Submission of Safety and Effectiveness Information. http://www.gpo.gov/fdsys/pkg/FR-2009-04-09/html/E9-8022.htm. Accessed January 10, 2013.
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