Device company meets with FDA regarding Revelation Tx.

2004 JUL 19 - (NewsRx.com & NewsRx.net) -- Cardima (CRDM) announced that it met with the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) on June 18, 2004, in response to the FDA's encouragement for Cardima to meet with FDA representatives subsequent to the issuance of the FDA's letter stating that Cardima's Revelation Tx Microcatheter system premarket approval application (PMA) was not approvable.

As previously announced, the non-approvable letter was received by Cardima on May 28, 2004, and it informed Cardima that the FDA had determined that Cardima's Revelation Tx Microcatheter with NavAblator Ablation System …