The de novo
application details the results of the existing FDA-approved XPAND pivotal trial of 150 patients which successfully met its primary endpoint of demonstrating that the AeroForm tissue expander is a safe and effective method of expansion as an alternative to saline tissue expansion, to successfully expand the tissue and exchange to permanent breast implants.
In accordance with the current statutory provisions, the draft guidance notes that a de novo
petition may be submitted to FDA either: (1) following a negative decision on a 510(k) submission based on a lack of predicate device, or (2) a direct de novo
To develop and validate a model to predict the risk of de novo
SUI within 12 months of prolapse surgery Dr.
David Novo, De Novo
Software's president said, "This is an ideal collaboration and business relationship, providing mature analysis and reporting tools for the ImageXpress Velos Cytometer and Molecular Devices imaging customers.
Therefore, for the purpose of this solicitation, grant applications proposing technology development for de novo
sequencing shall describe how they will achieve, for about $1000, a draft-quality assembly that is at least comparable to that represented by the mouse draft sequence produced by December 2002: 7.
D, founder and chief scientific officer of De Novo
The Court remanded the case for application of the de novo
We are pleased to be working with De Novo
Pharmaceuticals as further validation of the value and utility of large-scale protein structural information as we assist De Novo
in meeting their customers' discovery objectives.
Based on these empirical observations, I develop a simple life-cycle theory of de novo
bank failure, in which the probability of failure at first rises, and then declines with the age of the new bank.
We constructed three ownership categories, de novo
private firms, "socially" owned and privatized enterprises.
The court also rejected the former employees' argument that eligibility determinations are questions of law subject to de novo
experts will make several presentations about the recently streamlined de novo
process, an alternative regulatory pathway to market, and the challenges of medical device clinical trials.