<!– –> <!– Page Last Updated: 08/01/2016 –> Page Last Updated: 08/01/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Consumer Information on: Integra Omnigraft Dermal Regeneration Matrix – Interactive Wound Dressing
<!– –> <!– Page Last Updated: 08/01/2016 –> Page Last Updated: 08/01/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Consumer Information on: Sorin Perceval Sutureless Heart Valve
<!– –> <!– Page Last Updated: 08/01/2016 –> Page Last Updated: 08/01/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Consumer Information on: Storz Medical Duolith SD1 Shock Wave Therapy Device
<!– –> <!– Page Last Updated: 08/01/2016 –> Page Last Updated: 08/01/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
FY 2017 Medical Device User Fee Small Business Qualification and Certification
%PDF-1.7 % 2439 0 obj stream
Letter: Important Information on Medical Device User Fees for Fiscal Year 2017 (October 1, 2016 through September 30, 2017)
August 1, 2016 Dear Medical Device Establishment: This letter provides information regarding medical device user fees, including fee rates and payment procedures, for Fiscal Year 2017 (FY17), which runs from October 1, 2016 through September 30, 2017. Federal Law (Food and Drug Administration Safety and Innovation Act – FDASIA) authorizes the U.S. Food and Drug…
Consumer Information on: Axium Neurostimulator System
<!– –> <!– Page Last Updated: 08/01/2016 –> Page Last Updated: 08/01/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Consumer Information on: CyPass® System (Model 241-S)
<!– –> <!– Page Last Updated: 07/29/2016 –> Page Last Updated: 07/29/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
AVEA Ventilator by CareFusion: Class I Recall
<!– –> <!– Page Last Updated: 07/28/2016 –> Page Last Updated: 07/28/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
General Wellness: Policy for Low Risk Devices
%PDF-1.7 % 697 0 obj stream