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Home » Rulemaking » Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems (IABP) for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for IABP for Other Specific Intended Uses

Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems (IABP) for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for IABP for Other Specific Intended Uses

Document ID: FDA-2013-N-0581-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Medical Devices
Federal Register Number: 2013-14553
CFR Citation: 21 CFR Part 870
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Details Information

Document Subtype: Notice of Proposed Rulemaking (NPRM)
Received Date: June 19 2013, at 12:00 AM Eastern Daylight Time
Start-End Page: 36702 - 36711
Page Count: 10
Comment Start Date: June 19 2013, at 12:00 AM Eastern Standard Time
Comment Due Date: September 17 2013, at 11:59 PM Eastern Standard Time

Attachments:

Reference 1 Intra Aortic Balloon Counterpulsation in U.S. and non US Centres Results of the Benchmark Registered Trademark Registry

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Reference 10 Circulatory System Devices Panel Transcript

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Reference 2 Intraaortic Balloon Support for Myocardial Infarction With Cardiogenic Shock

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Reference 3 Use of Intraaortic Balloon Counterpulsation in Patients Presenting With Cardiogenic Shock Observations from the GUSTO I Study

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Reference 4 Relation Between Hospital Intra Aortic Balloon Counterpulsation Volume and Mortality in Acute Myocardial Infarction Complicated by Cardiogenic Shock

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Reference 5 The Use of Intraaortic Balloon Counterpulsation in Patients With Cardiogenic Shock Complicating Acute Myocardial Infarction Data From the National Registry of Myocardial Infarction 2

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Reference 6 The Role of Intraaortic Counterpulsion in High Risk OPCAB Surgery A Prospective Randomised Study

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Reference 7 Prophylactic Intra Aortic Balloon Pump in High Risk Patients Undergoing Coronary Artery Bypass Grafting A Propensity Score Analysis

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Reference 8 Intra Aortic Balloon Counterpulsation in Decompensated Cardiomyopathy Patients Bridge to Transplantation or Assist Device

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Reference 9 Intra Aortic Balloon Counterpulsation as a Bridge to Cardiac Transplantation Effects in Nonischemic and Ischemic Cardiomyopathy

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