CDRH New Update

CDRHNew

Date: August 2, 2016

The following new items were added to the CDRH web pages on August 1, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Consumer Information on: Axium Neurostimulator System - P150004
• Consumer Information on: Blazer Open-Irrigated Ablation Catheter - P150005
• FY 2017 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments
• Consumer Information on: Integra Omnigraft Dermal Regeneration Matrix - Interactive Wound Dressing - P900033S042
• Letter: Important Information on Medical Device User Fees for Fiscal Year 2017 (October 1, 2016 through September 30, 2017)
• Consumer Information on: Sorin Perceval Sutureless Heart Valve - P150011
• Consumer Information on: Storz Medical Duolith SD1 Shock Wave Therapy Device - P080028