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