Circulatory Systems Devices Panel

April 23, 2001

Sulzer IntraTherapeutics, Inc.
P000033, IntraCoil Self-Expanding Peripheral Stent

Briefing Information

Disclaimer

The statements contained in this document 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.

Draft Instructions for Use   pdf   html

Trial Design Issues Associated with Evaluation of Stents in Diseased Iliac Arteries   pdf   html

FDA Presentation   text   pdf   ppt