Cardiovascular Devices: Reclassification of External Pacemaker Pulse Generator Devices

Document ID: FDA-2011-N-0650-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Medical Devices
Federal Register Number: 2011-26625
CFR Citation: 21 CFR Part 870
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Details Information

Document Subtype: Notice of Proposed Rulemaking (NPRM)
Received Date: October 17 2011, at 12:00 AM Eastern Daylight Time
Start-End Page: 64224 - 64227
Page Count: 4
Comment Start Date: October 17 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: January 17 2012, at 11:59 PM Eastern Standard Time

Attachments:

Reference 1 - ACC-AHA Guidelines for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices

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Reference 2 External Pacemaker Pulse Generator SCGD

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Comments

   
Total: 3
Public Citizen - Comment
Posted: 02/14/2012     ID: FDA-2011-N-0650-0003

Jan 17,2012 11:59 PM ET
Patient, Consumer, and Public Health Coalition - Comment
Posted: 02/14/2012     ID: FDA-2011-N-0650-0004

Jan 17,2012 11:59 PM ET
R Bogenschutz - Comment
Posted: 12/22/2011     ID: FDA-2011-N-0650-0002

Jan 17,2012 11:59 PM ET

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