Food and Drug Administration

Circulatory System Devices Panel

October 2, 2003

Briefing Information

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Summary of Statistical Clinical Review, FDA (HTM) (PDF) (Word)

Summary of Lead Review, FDA (HTM) (PDF) (Word)

Summary of FDA Clinical Review, FDA (HTM) (PDF) (Word)

FDA Presentation (HTM) (PPT)

Summary of Safety and Effectiveness Data LACI, Spectranetics Corp. (HTM) (PDF) (Word)

CLiRpathä Excimer Laser Catheters, Spectranetics Corp. (HTM) (PDF) (Word)

LACI Clinical Summary, Spectranetics Corp. (HTM) (PDF) (Word)

Sponsor's Presentation, Spectranetics, Corp.(HTM) (PPT)