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Anesthesiology Devices: Reclassification of Membrane Lung for Long-Term Pulmonary Support, etc.

Document ID: FDA-2012-N-1174-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Medical Devices
Federal Register Number: 2013-00086
CFR Citation: 21 CFR Parts 868 and 870
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Details Information

Document Subtype: Notice of Proposed Rulemaking (NPRM)
Received Date: January 08 2013, at 12:00 AM Eastern Standard Time
Start-End Page: 1158 - 1162
Page Count: 5
Comment Start Date: January 8 2013, at 12:00 AM Eastern Standard Time
Comment Due Date: April 8 2013, at 11:59 PM Eastern Standard Time

Attachments:

Reference 1 Mechanical Component Failures in 28,171 Neonatal and Pediatric Extracorporeal Membrane Oxygenation Courses From 1987 to 2006

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Reference 2 Update on Extracorporeal Membrane Oxygenation

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Comments

   
Total: 2
MAQUET Cardiopulmonary AG - Comment
Posted: 05/17/2013     ID: FDA-2012-N-1174-0002

Apr 08,2013 11:59 PM ET
Public Citizen's Health Research Group - Comment
Posted: 05/17/2013     ID: FDA-2012-N-1174-0003

Apr 08,2013 11:59 PM ET

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