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Earl's View

Tag Archives: Premarket Approval

Profile of an FDA critic: Q&A with patient safety advocate Dr. Robert Hauser | MassDevice

March 24, 2013

Profile of an FDA critic: Q&A with patient safety advocate Dr. Robert Hauser | MassDevice. March 11, 2013 by Arezu …

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FDA Aims To Smooth Premarket Review process | Bloomberg BNA

August 24, 2012

FDA Aims To Smooth Premarket Review process | Bloomberg BNA. Wednesday, August 22, 2012 FDA Aims To Smooth Premarket Review …

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Pre Market Approval – Why does the Law shelter Smith & Nephew & others like them?

August 20, 2012

Premarket Approval by the FDA – why do we lose out? Reading this recent law review article by Professor Ralph Hall, …

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Rival Tried to Block FDA Approval of Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device | NewsInferno

July 29, 2012

Rival Tried to Block FDA Approval of Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device | NewsInferno. Rival Tried to …

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Wright Medical Filed Petition to Block Smith & Nephews Metal Implant

July 25, 2012

Wright Medical Filed Petition to Block Smith & Nephews Metal Implant. Wright Medical Filed Petition to Block Smith & Nephews …

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FDA – Overview of Medical Device Regulation > Information about MDUFA III

July 15, 2012

Overview of Medical Device Regulation > Information about MDUFA III. Information about MDUFA III Congress recently authorized the Medical Device …

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Smith & Nephew BHR FDA-required Post-Approval Studies

July 15, 2012

Smith & Nephew BHR FDA-required Post-Approval Studies Post-Approval Studies In January 2005, the oversight responsibility of the Post-Approval Studies Program …

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Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions

July 14, 2012

Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions. FDA NEWS RELEASE For Immediate Release: …

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METAL ON METAL TOTAL HIP RESURFACING AS AN ALTERNATIVE TO TOTAL HIP ARTHROPLASTY

July 8, 2012

CTAF ASSESSMENT – METAL ON METAL TOTAL HIP RESURFACING AS AN ALTERNATIVE TO TOTAL HIP ARTHROPLASTY http://www.google.com.au/url?sa=t&rct=j&q=&esrc=s&source=web&cd=42&ved=0CFIQFjABOCg&url=http%3A%2F%2Fwww.ctaf.org%2Ffiles%2F769_file_Hip_resurfacing_W.pdf&ei=Ovr4T5bGI-yUiAfA5tzhBg&usg=AFQjCNGpF8andIjM3eQZ9JGMI58FwHyo7w&sig2=IPuN6AUkPw1Tt6yzEYt32Q. Or download the …

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Outcomes of Birmingham Hip Resurfacing: A Systematic Review

July 8, 2012

Outcomes of Birmingham Hip Resurfacing: A Systematic Review. Asian J Sports Med. 2012 March; 3(1): 1–7. PMCID: PMC3307960 Outcomes of Birmingham Hip Resurfacing: …

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SMITH & NEPHEW BHR – FDA Papers – Appendix G: Summary of MoM Hip Resurfacing Post-Approval Studies

July 8, 2012

SMITH & NEPHEW BHR – FDA Papers – Appendix G:  Summary of MoM Hip Resurfacing Post-Approval Studies Source: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM309356.pdf. Download PDF …

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Smith & Nephew BHR – Food and Drug Administration, HHS

July 8, 2012

http://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol8/pdf/CFR-2011-title21-vol8-sec888-5.pdf. PDF File: Food and Drug Administration, HHS CFR-2011-title21-vol8-sec888-5 Food and Drug Administration, HHS 513(f) of the act) into class III …

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SUMMARY OF SAFETY AND EFFECTIVENESS DATA PREMARKET APPROVAL APPLICATION P040033 SMITH & NEPHEW BHR BIRMINGHAM HIP RESURFACING SYSTEMf

July 8, 2012

Source: www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4181b1_03_SSED_BHR_080505.pdf. SUMMARY OF SAFETY AND EFFECTIVENESS DATA PREMARKET APPROVAL APPLICATION P040033  SMITH & NEPHEW BHR   BIRMINGHAM HIP RESURFACING SYSTEM …

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FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR…

July 7, 2012

FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR… http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-pdn0001-vol2.pdf. Dear Mr.  Roberts: Food and Drug …

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Premarket Approval (PMA) Database – BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

July 7, 2012

MDRWeb Medical Device Register On-line from Canon Communications, LLC. Premarket Approval (PMA) Database Premarket Approval (PMA) Database Trade Name: BIRMINGHAM …

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Smith & Nephew – BHR PMA – FIRST OF A KIND PMA – WHO PULLED WHAT STRINGS????

July 7, 2012

http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm127516.pdf. Hip Prostheses The Birmingham Hip Resurfacing (BHR) System, P040033, by  Smith & Nephew Orthopaedics was approved on May 9, …

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Despite the Reasons AGAINST – FDA Advisory Panel Recommends Conditional Approval of Smith & Nephew’s BIRMINGHAM HIP Resurfacing Technology

July 7, 2012

WHO PULLED WHAT STRINGS???? Smith & Nephew | FDA Advisory Panel Recommends Conditional Approval of Smith & Nephew’s BIRMINGHAM HIP …

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New FDA guidance on considerations used in device approval

July 7, 2012

New FDA guidance on considerations used in device approval. New FDA Guidance used in Device Approval THURSDAY, MARCH 29. 2012; FDA …

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FDA Proposes Guidelines That Clarify Benefit-Risk Determinations For Medical Devices

August 20, 2011

FDA Proposes Guidelines That Clarify Benefit-Risk Determinations For Medical Devices August 19, 2011  Source: Medical Design Online For the first …

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Corin Cormet FDA Approval – At Least the FDA Panel included Metal Ion Serum Levels

July 7, 2011

Orthopaedic and Rehabilitation Devices Panel – February 22, 2007 The Orthopaedic and Rehabilitation Devices Panel (the Panel) met on Thursday, …

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There are over 1,600 posts on this site - and about 30 pages too. The best way to find what you want is to type in the search box.

The front page (home) has the latest post and immediately below it, the last 100 or so which you can click and surf through.

I would love to record your story - we have so much in common I am sure - send it to me via the contact page & then I will be in touch.

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Recent Posts

  • Detailed briefing for FDA on the complications of CoCr arthroprosthetic Metallosis – Dr Stephen Tower
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  • Dr Steve Tower update for Producers of the Netflix documentary – The Bleeding Edge
  • New hip resurfacing implant could lead to better outcomes for patients?
  • A MAN DESTOYED: THE BIRMINGHAM HIP RESURFACING DISTASTER

Top Posts

  • Guess it makes sense that DePuy is now Pushing a Hip Revision System!!!
  • Stryker Trident Hip Replacement System Recall
  • What does the FDA have to Hide? Who do they work for??
  • Hip Dysplasia - all you didn't want to know!
  • Birmingham Hip Resurfacing Lawsuits | Dallas-Fort Worth Legal Examiner | Dallas-Fort Worth Texas Personal Injury Lawyer
  • Smith and Nephew Issues Failure Warning on Metal Hip Implant - Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts
  • McMinn Centre (UK) Talks About Arthritis
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  • FINALLY --- New rules to end secrecy over safety of medical implants - Telegraph

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