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» Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer
Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer
Document ID:
FDA-2011-N-0526-0001
Document Type:
Proposed Rule
Agency:
Food And Drug Administration
Topics:
Medical Devices
Federal Register Number:
2011-19733
CFR Citation:
21 CFR Part 870
View Document:
Details Information
Document Subtype:
Notice of Proposed Rulemaking (NPRM)
Received Date:
August 04 2011, at 12:00 AM Eastern Daylight Time
Start-End Page:
47085 - 47089
Page Count:
5
Comment Start Date:
August 4 2011, at 12:00 AM Eastern Standard Time
Comment Due Date:
November 2 2011, at 11:59 PM Eastern Standard Time
Comments
Total:
1
National Research Center for Women & Families - Comment
Posted:
11/22/2011
ID:
FDA-2011-N-0526-0002
Comment Period Closed
Nov 02,2011 11:59 PM ET
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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 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
Effective Dates of Requirements for Premarket Approvals: Automated External Defibrillator System
Cardiovascular Devices; Reclassification of External Cardiac Compressor
Effective Date of Requirement for Premarket Approval: Cardiovascular Permanent Pacemaker Electrode
Effective Date Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator
Effective Date Requirement for Premarket Approval for a Pacemaker Programmer
Medical Devices: Cardiovascular Devices; Classification of Endovascular Suturing System
Cardiovascular Devices: Reclassification of External Pacemaker Pulse Generator Devices
Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode; Correction
Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode
Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator
Cardiovascular Devices: Classification of Electrocardiograph Electrodes
Cardiovascular Devices: Reclassification of Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters
Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer
Details Information
Comments
Posted: 11/22/2011 ID: FDA-2011-N-0526-0002
Nov 02,2011 11:59 PM ET
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