Clinical Information
Clinical Site Locations
Clinical Studies

 

Clinical Information

In August 2000, the Company received FDA review and acceptance for its five-step (module) pre-market approval (PMA) submission plan. The first data module of the plan was submitted and accepted shortly thereafter. Modules 2 and 3 were submitted in Q2 and Q3 and accepted by the FDA in Q4 2001. Module 4 was submitted and accepted in 2002. The Company is taking action to complete the final module as quickly as possible so that final submission to the FDA can be made, with the expectation of obtaining FDA approval. Marketing efforts in the United States will begin soon thereafter.

 
 


calendario | newsletter | relacoes | atribuicoes | acidentesincidentes | legisot | reflegisd | apresentacao | missao | contactos
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 1 | 2 | 3 | 4 | 5