USFDA CDRH - List of Medical Devices Cleared/Approved in the 2014...

The products listed in this section include some of the newest medical technology from the year 2014. 

The products in each list contain information about what medical uses the device is cleared or approved for, when it can be used, and when it should not be used. 

This information, along with information from your doctor and other sources, can help make you an informed participant in your health care.

Medical Devices Cleared or Approved by FDA in 2014

Device Name	Category	Date
Medtronic IN.PACT Admiral Paclitaxel-coated PTA Balloon Catheter - P140010	Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter	12/30/14
Bellafill PMMA Collagen Dermal Filler - P020012/S009	Dermal filler	12/23/14
BRACAnalysis CDx - P140020	Ovarian Cancer	12/19/14
TECNIS Multifocal 1-Piece Intraocular Lens (IOL), Models ZKB00 (+2.75 D) and ZLB00 (+3.25 D) - P980040/S049	Artificial Lenses	12/17/14
Barostim neo Legacy System - H130007	Implantable Pulse Generator (IPG)	12/12/14
Animas Vibe System - P130007	Glucose Monitoring	11/25/14
IDEAL IMPLANT Saline-filled Breast Implant - P120011	Breast Implants	11/14/14
TactiCath Quartz Contact Force Ablation Catheter and TactiSys Quartz Equipment - P130026	Catheter	10/24/14
Dexcom G4 PLATINUM Continuous Glucose Monitoring System - P120005/S018	Glucose Monitoring	10/21/14
EverFlex Self-Expanding Peripheral Stent System – P110023/S007	Stent	10/10/14
Lutonix 035 Drug Coated Balloon PTA Catheter - P130024	Angioplasty	10/09/14
XIENCE Family of Everolimus Eluting Coronary Stent Systems - P070015/S122 and P110019/S066	Stent	10/03/14
GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface - P040037/S060	Stent	09/19/14
SenoClaire - P130020	Mammography	08/26/14
Pleximmune - H130004	Blood Test	08/26/14
XPS System with STEEN Solution Perfusate - H120003	Lung Transplant	08/12/14
Cologuard - P130017	Stool Test	08/11/14
Low-Profile Visualized Intraluminal Support Device (LVIS and LVIS Jr.) - H130005	Stent	07/25/14
Prestige LP Cervical Disc - P090029	Cervical Disc	07/24/14
REBEL Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) - P130030	Stent	06/27/14
Sorin Freedom SOLO Stentless Heart Valve and SOLO Smart Stentless Heart Valve - P130011	Stentless Heart Valve	06/24/14
Fluency Plus Endovascular Stent Graft - P130029	Endovascular Stent Graft	06/17/14
Edwards SAPIEN XT Transcatheter Heart Valve - P130009	Heart Valve	06/16/14
Restylane Silk Injectable Gel - P040024/S072	Injection	06/13/14
Medtronic CoreValve System - P130021/S002	Aortic Heart Valve	06/12/14
artus CMV RGQ MDx Kit - P130027	Cytomegalovirus (CMV) DNA Test	06/02/14
CardioMEMS HF System - P100045	Pulmonary Artery Pressure	05/28/14
therascreen KRAS RGQ PCR Kit - P110027	Automated Molecular Assay	05/23/14
ADVIA Centaur® HBsAgII - P110041	hepatitis B virus (HBV)	05/16/14
GEL-SYN - P110005	Osteoarthritis	05/09/14
Inspire Upper Airway Stimulation - P130008	Obstructive Sleep Apnea	04/30/14
cobas® HPV Test - P100020/S008	HPV Test	04/24/14
Medtronic CRT-P and CRT-D Devices - P010015/S205 and P010031/S381	Pacemaker/Defibrillator	04/10/14
Supera Peripheral Stent System – P120020	Peripheral Stent	03/28/14
Nucleus® Hybrid™ L24 Cochlear Implant System – P130016	Cochlear Implant System	03/20/14
Elecsys® HBeAg Immunoassay and Elecsys® PreciControl HBeAg - P130015	Hepatitis B Test	03/14/14
MONOVISC™ - P090031	Joints	02/25/14
Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System - P120005/S002	Glucose Monitoring	02/03/14
Medtronic Valiant Thoracic Stent Graft with Captivia Delivery System - P100040/S012	Stent Graft	01/22/14
Medtronic CoreValve System - P130021	Artificial aortic valve	01/17/14
ReSure® Sealant - P130004	Surgical Sealant	01/08/14

USFDA approved EverFlex Self-Expanding Peripheral Stent System of ev3, Inc...

Product Name: EverFlex Self-Expanding Peripheral Stent System
Manufacturer: ev3, Inc.
Address: 3033 Campus Drive, Suite #N550, Plymouth, MN 55441
Approval Date: October 10, 2014

What is it?

The EverFlex Self-Expanding Peripheral Stent System is a thin, flexible, metal mesh tube that is implanted in the arteries that supply blood to the pelvis and legs (iliac arteries). The System consists of two parts, the stent and the delivery system. The stent is an implant made of a nickel-titanium alloy (nitinol) tubing and laser cut into a mesh shape. The stent is mounted in a long, thin, tube-like device called the delivery catheter.

How does it work?

• A catheter with a deflated balloon at its tip is inserted into a blood vessel in the groin and advanced within the vessel to the narrowed section of the iliac artery.
• The balloon is inflated within the narrowed artery to open the artery by pushing the fatty material (plaque) against the artery wall (balloon angioplasty).
• The angioplasty balloon and its catheter are removed; then the EverFlex Self-Expanding Peripheral Stent System is advanced through the same blood vessel and positioned within the expanded artery.
• After it is positioned in the artery, the stent opens automatically over the blockage and is placed in the artery by withdrawing the outer tube (sheath).
• The delivery system is removed, and the stent remains permanently implanted in the iliac artery and acts as a support for the newly-opened section of the artery.

When is it used?

The stent is used in patients who have a narrowing in their iliac arteries caused by atherosclerosis - the collection of plaque along the lining of the arteries.

What will it accomplish?
Once in place, the stent permanently holds open a narrowed iliac artery and improves blood flow to the pelvis and legs.

When should it not be used?

Generally, patients who are not suitable candidates for balloon angioplasty are also not suitable candidates for stent placement. The EverFlex Self-Expanding Peripheral Stent System should also not be used in patients who:

• Cannot take medicines that thin the blood or prevent blood clots.
• Have known allergies to the metals in the stent.
• Have a blockage that will not allow complete inflation of the angioplasty balloon or proper placement of the stent.

Approval Letter: CLICK HERE TO VIEW/DOWNLOAD

Australian Government proposed to bypass TGA for medical devices with CE Marking...

Under the Leadership of Prime Minister Tony Abbott Australian Government has proposed to allow domestic medical device manufacturers to register their routine products in the country using CE Marking certificates from European Notified Bodies.

This proposal which is part of new government  position paper pushing innovation with competitiveness issue in essence to remove TGA Certification requirements for Australian medical devices that have received CE Marking from European Authorities.

TGA allow import of medical devices with CE Marking from foreign manufacturers, even domestic manufacturers that have received CE Marking for their products still have to register with TGA for marketing authorization to market in Australia.

For more information view/download the Position Paper on Industry Innovation and Competitiveness of Australian Government.

to register their “routine” products in the country using CE Marking certificates from European Notified Bodies - See more at: http://www.raps.org/Regulatory-Focus/News/2014/10/22/20608/Australian-Government-Proposes-Bypassing-TGA-for-Medical-Devices-with-CE-Marking/#sthash.tjxSuOxM.dpuf

to register their “routine” products in the country using CE Marking certificates from European Notified Bodies. - See more at: http://www.emergogroup.com/blog/2014/10/australian-government-proposes-bypassing-tga-medical-devices-ce-marking#sthash.ESZxrSZx.dpuf

USFDA CDRH New Device Approvals: XPS System with STEEN Solution Perfusate...

The FDA has recently approved the XPS System with STEEN Solution Perfusate to be marketed.  The XVIVO Perfusion System (XPS) with STEEN Solution Perfusate preserves donated lungs that do not initially meet the standard criteria for lung transplantation but may be transplantable if there is more time to observe and evaluate the organ’s function. 

Product Name: XVIVO Perfusion System (XPS) with STEEN Solution Perfusate
HDE Applicant: XVIVO Perfusion, Inc.
Address:  3666 S Inca Street, Englewood, CO  80110
Approval Date: August 12, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf12/H120003a.pdf

What is it?  The XVIVO Perfusion System (XPS) with STEEN Solution Perfusate preserves donated lungs that do not initially meet the standard criteria for lung transplantation but may be transplantable if there is more time to observe and evaluate the organ’s function.

The XPS System consists of hardware, software, STEEN solution, tubing sets, and an organ chamber. The XPS System houses the organ for preservation and perfuses it with a preservation solution, during which time the lungs can be assessed by the transplant surgeon. The STEEN Solution temporarily maintains the isolated lungs after removal from the donor.

When is it used?  The XPS System with STEEN Solution Perfusate is used to flush and preserve initially unacceptable donor lungs after removal and prior to transplantation, if they are found suitable for transplantation after reassessment.

For detailed information please CLICK HERE

General Electric's 3D mammography device gets US FDA approval...

General Electric Co's healthcare unit last week won US Food and Drug Administration approval for its mammography device that produces three-dimensional images to detect breast cancer.

According to the company's website, the device, SenoClaire, uses imaging technology that combines low radiation-dosed X-rays from multiple angles to produce a superior mammogram.

The device consists of hardware and software upgrades to the company's previously launched Senographe Essential 2D full-field digital mammography system.

The hardware upgrade produces multiple, low-dose x-ray projection images of the breast. The software upgrade uses the low-dose X-ray images to create cross-sectional views of the breast.

Hologic Inc came up with one of the first 3-D breast imaging devices in 2001, which continues to dominate the market. Siemens AG submitted its application for the approval of its own 3-D breast imaging device in June.