21
Participants
Start Date
November 30, 2007
Primary Completion Date
June 30, 2008
Study Completion Date
August 31, 2008
CryoSpray Ablation System
"CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications (K070893). As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold"
Franklin Square Hospital Center, Baltimore
Lead Sponsor
CSA Medical, Inc.
INDUSTRY