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ThermaSolutions Cited for Uncleared Uses
CDRH has cited ThermaSolutions for marketing its ThermoChem-HT 1000 system for indications not included in its initial clearance. A May 7 Warning Letter said the firm obtained a 510(k) clearance for the device “to raise the core temperature of the peritoneum to the desired target temperature by continuously lavaging the peritoneum with circulating warmed Lactated Ringer’s Solution or another physiologically compatible sterile solution.”
Jim Dickinson
June 25, 2012
1 Min Read
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However, the letter said, the firm’s Web site promoted its hyperthermia medical technology for use in ovarian, gastric, and colorectal cancers. The Web site also allegedly discussed doctors using the system during a hyperthermic intraperitoneal chemotherapy (HIPEC) proocedure. And it mentioned use of the device in a HIPEC procedure as part of a “Grey’s Anatomy” TV show.
The company was told to stop marketing the system for unapproved used and to notify FDA of specific steps taken to correct the violations, including documentation of the corrections and a timetable for completion.
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