eLaws | eCases | United States Code | Federal Courts |
Home » Rulemaking » Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode

Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode

Document ID: FDA-2011-N-0505-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Medical Devices
Federal Register Number: 2011-19959
CFR Citation: 21 CFR Part 870
View Document:  View as format pdf View as format html

Details Information

Document Subtype: Notice of Proposed Rulemaking (NPRM)
Received Date: August 08 2011, at 12:00 AM Eastern Daylight Time
Start-End Page: 48058 - 48062
Page Count: 5
Comment Start Date: August 8 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: November 7 2011, at 11:59 PM Eastern Standard Time

Attachments:

Reference 1 - FY 2003 and FY 2004 United Costs for the Process of Medical Device Review

View Attachment: View as format pdf

Comments

Total: 0
No comments posted.

Related Documents

    More
Total: 14
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