PMA granted for Zimmer's NexGen LPS-Flex Mobile Knee

December 2007
Medical Device Daily;12/13/2007, Vol. 11 Issue 226, p10
The article reports that the U.S. Food and Drug Administration (FDA) has granted Zimmer Holdings' pre-market approval (PMA) application for the NexGen LPS-Flex Mobile Knee. Chief marketing officer Sheryl Conley said a number of orthopaedic surgeons prefer mobile bearing designs and they are pleased to be one only two firms that can offer the treatment option. She noted that the key strength of their system is its ability to be used in a minimally invasive procedure.


Related Articles

  • INDUSTRY NEWS.  // Orthopedics Today;Jul2010, Vol. 30 Issue 7, p69 

    This section offers news briefs related to orthopedics as of July 2010, including one on the web site of the U.S. Food and Drug Administration (FDA) which contains information on the safety of its recently approved drugs and biologics, another on the results of the clinical study on the...

  • TOP OF THE NEWS.  // Nonwovens Industry;Jun2010, Vol. 41 Issue 6, p12 

    The article offers news briefs related medical devices. The U.S. Food and Drug Administration (FDA) accused St. Jude Medical Inc. of alleged violation in the federal Food, Drug and Cosmetic Act due to off-label marketing of its Epicor surgical ablation devices. Zimmer Holdings Inc. opens a...

  • FDA Seeks Comments on its eCopy Program. Goedert, Joseph // Health Data Management;Dec2012, Vol. 20 Issue 12, p22 

    The article reports that the U.S. Food and Drug Administration (FDA) is seeking public comments on its draft guidance on the eCopy program for electronic submission of information on medical devices.

  • Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Extension of Comment Period. Kux, Leslie // Federal Register (National Archives & Records Service, Office of;3/25/2013, Vol. 78 Issue 57, p17934 

    This article presents a notice on accessible medical device labeling in a standard content and format public workshop issued by the U.S. Food and Drug Administration.

  • Regulating biomedical engineering to death.  // Machine Design;06/18/98, Vol. 70 Issue 11, p66 

    Questions the authority of United States' Food and Drug Administration in implementing regulations on the design of medical products. Provisions under the regulations; Implication to companies making medical devices; Influence on market competitiveness.

  • FDA addresses unmet pediatric medical device needs with three grants.  // Infectious Diseases in Children;Oct2009, Vol. 22 Issue 10, p56 

    The article announces the grants issued by the U.S. Food and Drug Administration (FDA) for the development of pediatric medical device.

  • Extreme Weather Effects on Medical Device Safety and Quality. Kux, Leslie // Federal Register (National Archives & Records Service, Office of;2/21/2013, Vol. 78 Issue 35, p12067 

    This article presents a notice of request for comments on extreme weather effects on medical device safety and quality issued by the U.S. Food and Drug Administration (FDA).

  • Approval Isn't Everything. Kagan, Cara // Town & Country;Mar2007, Vol. 161 Issue 5322, p122 

    This article focuses on an explanation made by Richard G. Glogau, a professor of clinical dermatology at the University of California-San Francisco, regarding the U.S. Food and Drug Administration's separate approval process for medical devices and drugs.

  • FDA proposes new tanning bed requirements, including skin cancer warnings.  // Hem/Onc Today;6/25/2013, Vol. 14 Issue 12, p47 

    The article focuses on a proposal by the U.S. Food and Drug Administration (FDA) to reclassify sunlamp products from low-risk to moderate-risk devices.


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics