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Cardiovascular Devices; Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina; Effective Date of Requirement for Premarket Approval for External Counter-Pulsating Devices for Other Specified Intended Uses

Document ID: FDA-2013-N-0487-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Medical Devices
Federal Register Number: 2013-12122
CFR Citation: 21 CFR Part 870
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Details Information

Document Subtype: Notice of Proposed Rulemaking (NPRM)
Received Date: May 21 2013, at 12:00 AM Eastern Daylight Time
Start-End Page: 29672 - 29680
Page Count: 9
Comment Start Date: May 21 2013, at 12:00 AM Eastern Standard Time
Comment Due Date: August 19 2013, at 11:59 PM Eastern Standard Time

Attachments:

Reference 1 The Multicenter Study of Enhanced External Counterpulsation MUST EECP Effect of EECP on Exercise Induced Myocardial Ischemia and Anginal Episodes

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Reference 10 New Graduated Pressure Regimen for External Counterpulsation Reduces Mortality and Improves Outcomes in Congestive Heart Failure: A Report From the Cardiomedics External Counterpulsation Patient Registry

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Reference 11 Clinical Assessment of External Pressure Circulatory Assistance in Acute Myocardial Infarction

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Reference 2 Effects of Enhanced External Counterpulsation on Health Related Quality of Life Continue 12 Months After Treatment A Substudy of the Multicenter Study of Enhanced External Counterpulsation

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Reference 3 Coronary Collateral Growth by External Counterpulsation A Randomised Controlled Trial

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Reference 4 Effects of Enhanced External Counterpulsation on Arterial Stiffness and Myocardial Oxygen Demand in Patients With Chronic Angina Pectoris

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Reference 5 The Panel Transcript and Other Meeting Materials

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Reference 6 Enhanced External Counterpulsation Improves Exercise Duration and Peak Oxygen Consumption in Older Patients With Heart Failure A Subgroup Analysis of the PEECH Trial

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Reference 7 Enhanced External Counterpulsation Improves Exercise Tolerance in Patients With Chronic Heart Failure

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Reference 8 Clinical Effects of Enhanced External Counterpulsation Treatment in Patients With Ischemic Heart Failure

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Reference 9 Efficacy of Enhanced Aortic Diastolic Pressure With An External Counterpulsation Method in the Acute Myocardial Infarction

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