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Food and Drug Administration

Circulatory System Devices Panel

June 27, 2007

BRIEFING INFORMATION

Cryocor Cryoablation System P050024

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.

CryoCor- Executive Summary (pdf)

SSED Draft (pdf)

Cryoablation Catheter (pdf)

Cryoablation Console- Users Manual (pdf)

Serial Number label EKG label fuse label (pdf)

CryoBlator X-05 label 1 (pdf)

030-05450-002 US CryoBlator X-07 label 1 (pdf)

US Ground and Voltage labels (pdf)

030-02665-001 Storage and Humidity label (pdf)

030-04544 display label and logo label (pdf)

030-04997-001 open other end label (pdf)

FDA

Disclaimer

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552). These redacted portions will appear as white space on the screen or on the printed page.

FDA Executive Summary (pdf)


Page last updated June 15, 2007 kkhorizonal rule
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