FDA: Page 25

RITA gets 510(k) for new ablation electrode
By AuntMinnie.com staff writers
RITA Medical Systems of Mountain View, CA, has received 510(k) clearance from the FDA for the latest addition to its line of radiofrequency ablation electrodes.
May 4, 2003
Imaging Diagnostic Systems files PMA
By AuntMinnie.com staff writers
Laser breast imaging developer Imaging Diagnostic Systems (IDS) has submitted a Premarket Approval Application (PMA) with the U.S. Food and Drug Administration seeking marketing approval for its computed tomography laser mammography (CTLM) system.
April 29, 2003
PointDx receives 510(k) clearance
By AuntMinnie.com staff writers
Structured-reporting developer PointDx has received Food and Drug Administration 510(k) marketing clearance for the firm’s REX workstation 3.0.
April 8, 2003
Siemens files PMA for FFDM system
By AuntMinnie.com staff writers
Siemens Medical Solutions of Malvern, PA, has filed a premarket approval (PMA) application with the Food and Drug Administration for its first full-field digital mammography system, Mammomat NovationDR.
April 6, 2003
EPMedSystems files 510(k) for ultrasound catheter system
By AuntMinnie.com staff writers
Electrophysiology equipment developer EPMedSystems has submitted a 510(k) filing with the U.S. Food and Drug Administration for regulatory approval of its ViewMate intracardiac ultrasound catheter system.
April 3, 2003
Boston Scientific starts Taxus V clinical trials
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific has started a new clinical trial to evaluate the use of a slow-release formulation of its Taxus paclitaxel-eluting coronary stent system in high-risk patients.
March 17, 2003
Boston Scientific submits stent for PMA
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific of Natick, MA, has submitted the first module of a premarket approval application for its Taxus paclitaxel-eluting coronary stent system to the Food and Drug Administration.
February 24, 2003
Final 510(k) decisions for January 2003
Issued February 5, 2003
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of devices approved for marketing in the U.S. during the previous month. The following is a list of 510(k) final decisions rendered for January 2003.
February 5, 2003
FDA nixes Computerized Thermal Imaging system
By AuntMinnie.com staff writers
The Food and Drug Administration has ruled that the premarket approval (PMA) application filed by Computerized Thermal Imaging for its thermal breast imaging system is not approvable in its current form.
January 27, 2003
Rita gets 510(k) for MR-compatible electrosurgical tool
By AuntMinnie.com staff writers
Radiation therapy firm RITA Medical Systems has received Food and Drug Administration 510(k) clearance for its MR-compatible RITA StarBurst XL, a radiofrequency ablation (RFA) device.
January 23, 2003
Final PMA approvals for December 2002
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of premarket approvals (PMA), product development protocols (PDP), supplement and notice decisions from the previous month. The following decisions were rendered for December 2002.
January 5, 2003
Final 510(k) decisions for December 2002
Updated January 6, 2003
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of devices approved for marketing in the U.S. during the previous month. The following is a list of 510(k) final decisions rendered for December 2002.
January 5, 2003
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