Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee

Anesthesiology and Respiratory Therapy Devices Panel
of the Medical Devices Advisory Committee

July 16, 2001

BRIEFING INFORMATION

Premarket approval application for a high-frequency ventilator used in the treatment of acute respiratory failure in adults

FDA Briefing Information

June 5 memo from FDA attachments reviews and panel questions pdf rtf

List of the PMA Material Sent to the Panel pdf html

Preliminary Clinical Review, May 31, 2001 pdf html

Preliminary FDA Engineering Review, June 4, 2001 pdf doc

Preliminary FDA Statistical Review, May 31, 2001 pdf doc

List of Published Reprints pdf html

Questions for the Manufacturer pdf html

FDA Questions for the Panel pdf html

June 25 memo from FDA re Cuff deflation and training pdf rtf

Sponsor 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.

PMA Summary pages 8-33 pdf doc

PMA Clinical Protocol (pages 105-142) pdf doc

PMA Sample Case Report Forms (page 142-152) pdf doc

PMA Site Information Outcome and Adverse Event List (Page 153-160) pdf doc

PMA Tabulation of Patients Who Died (Page 170-171) pdf doc

PMA Operator's Manual Pages, Correspond to PMA (Pages 485-601) pdf

SensMed Reponse to FDA Memo of June 5 see also rev. op manual pdf doc

Revised Operator's Manual (with MOAT-II) pdf doc

June 26 Cuff and Training Cover Memo from SensorMedics pdf doc

June 26 memo on Cuff Deflation During HFOV from SensorMedics pdf doc

June 26 Clinician Training Course Description SensorMedics pdf doc