FDA: Page 28

Final PMA approvals for January 2002

Issued February 28, 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 January 2002.

February 27, 2002

Final PMA approvals for December 2001

Revised February 25, 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 2001.

February 24, 2002

Final 510(k) approvals for January 2002

Issued February 5, 2002
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 2002.

February 4, 2002

Final 510(k) approvals for December 2001

Issued January 7, 2002
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 2001.

January 7, 2002

Final 510(k) approvals for November 2001

Issued December 5, 2001
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 November 2001.

December 4, 2001

CADx gets approvable letter for Second Look system

CHICAGO - The mammography market could soon see a new competitor in the computer-aided detection (CAD) niche. Canadian developer CADx Medical Systems this week received an approvable letter from the FDA for its Second Look CAD system. Once final premarket approval (PMA) is received, CADx will join R2 Technology as one of two companies able to market a CAD system in the U.S.

November 27, 2001

Final PMA approvals for October 2001

Issued November 7, 2001
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 October 2001.

November 6, 2001

Final 510(k) approvals for October 2001

Issued November 5, 2001
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 October 2001.

November 4, 2001

Hologic gets 510(k) for entry-level mammography system

By AuntMinnie.com staff writers

While it awaits FDA premarket approval for its full-field digital mammography system, Hologic of Bedford, MA, has received 510(k) clearance of an entry-level film-screen product, Lorad Affinity.

October 31, 2001

Final PMA approvals for September 2001

Issued October 26, 2001
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 September 2001:

October 25, 2001

Hologic gets FFDM approvable letter

By AuntMinnie.com staff writers

Hologic's Lorad division has received an approvable letter from the U.S. Food and Drug Administration for its Full-Field Digital Mammography system.

October 25, 2001

Imaging Diagnostic Systems gets Mexican install

By AuntMinnie.com staff writers

Laser breast imaging developer Imaging Diagnostic Systems of Fort Lauderdale, FL, has installed its CT laser mammography (CTLM) system at the Instituto Nacional de Cancerologia in Mexico.

October 9, 2001

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