FDA POSTS APPROVAL INFORMATION ON THREE DEVICES

The FDA has posted approval information for Japan-based Nidek's EC-5000 Excimer laser system. The device was approved Oct. 11 for use in conducting laser assisted in-situ keratomileusis, commonly known as LASIK, to correct a certain range of vision impairment in patients 21 or older.

The approval letter for the EC-5000 Excimer system can be viewed at www.fda.gov/cdrh/pdf/p970053s009a.PDF (http://www.fda.gov/cdrh/pdf/p970053s009a.PDF). The summary of product safety and effectiveness can be viewed at www.fda.gov/cdrh/pdf/p970053s009b.PDF (http://www.fda.gov/cdrh/pdf/p970053s009b.PDF).

The agency also posted approval information for EndoTex Interventional Systems' Nexstent carotid stent and delivery system and its carotid stent and monorail delivery system. The devices were approved Oct. 27 to treat patients at high risk for adverse events from carotid endarterectomy -- a procedure where plaque is removed from the carotid artery.

The systems are used in conjunction with the Boston Scientific FilterWire EZ embolic protection system, the FDA said in a product summary.

The approval letter can be viewed at www.fda.gov/cdrh/pdf5/p050025a.pdf (http://www.fda.gov/cdrh/pdf5/p050025a.pdf).

The product summary can be viewed at www.fda.gov/cdrh/pdf5/p050025b.pdf (http://www.fda.gov/cdrh/pdf5/p050025b.pdf).