News | June 10, 2011

FDA Announces New Device Approvals from April, May 2011

June 8, 2011 – The U.S. Food and Drug Administration (FDA) has released its list of pre-market approval (PMA) and 510(k) decisions for new or enhanced medical devices from March 2011. The list includes all FDA PMAs , product development protocols (PDP), supplement and notice decisions. This list is generated on a monthly basis.

PMAs are granted for new devices and 510(k) approvals are granted for device’s cleared commercialization that are substantially similar to a previously FDA cleared device.

The list of new PMAs can be accessed at www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm258003.htm

The list of new 510(k) decisions can be accessed at: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm258481.htm

Related Content

Merit Medical Announces Advanced Interventional Cardiology Transradial Intervention Education Course
News | Radial Access| August 23, 2017
Merit Medical Systems Inc. will partner with internationally renowned interventional cardiologist Ferdinand Kiemeneij,...
Houston Methodist Hospital Enters Multi-Year Technology and Research Agreement With Siemens Healthineers
News | Cardiac Imaging| August 17, 2017
Houston Methodist Hospital and Siemens Healthineers have entered into a multi-year agreement to bring cutting-edge...
Virtual Phantoms Inc. Releases VirtualDose-IR
Technology | Radiation Dose Management| August 07, 2017
Virtual Phantoms Inc. announced the release of VirtualDoseIR, a tool for assessing organ dose from interventional...
Moffitt Cancer Center Enhances Patient Care with Toshiba Medical's Infinix-i 4-D
News | Interventional Radiology| August 03, 2017
Cancer patients at Moffitt Cancer Center in Tampa, Fla., now have access to advanced diagnostic imaging for fast and...
Merge Hemo cath lab hemodynamics monitoring system.

Hemodynamic data shown on screens from the Merge Hemo recording system. It is among the newer generation hemodynamic systems for cath labs that are more user friendly and have technologies to speed workflow.

Feature | Hemodynamic Monitoring Systems| August 03, 2017 | Dave Fornell
The current generation of...
Sponsored Content | Videos | Peripheral Artery Disease (PAD)| July 25, 2017
This video case study, provided by Gore Medical, is titled "Tackling Complex Cases in Dialysis Access," by John Ross,
ACCESS PTS Study Demonstrates Efficacy of EKOS Therapy for Post-Thrombotic Syndrome
News | Deep Vein Thrombosis| July 07, 2017
BTG plc recently highlighted the results of the ACCESS PTS trial, presented at the Society for Vascular Medicine 28th...
Siemens Healthineers Announces First U.S. Install of Artis Pheno Angiography System
News | Angiography| July 05, 2017
Michigan Medicine recently became the first healthcare institution in the United States to install the Artis pheno, the...
Sponsored Content | Videos | Venous Therapies| June 27, 2017
This video, provided by Ekos, demonstrates the EkoSonic endovascular System thrombolytic system to treat deep vein th
Infab Introduces Revolution Lead Aprons
Technology | Radiation Dose Management| June 01, 2017
June 1, 2017 — Infab Corp.
Overlay Init