Recently Approved Devices

Resolute Integrity Zotarolimus Eluting Coronary Stent System - P110013/S088 The Resolute Integrity Zotarolimus Eluting Coronary Stent System is a drug-coated device that contains two components: the stent and the catheter delivery system with a balloon that will inflate to deploy the stent. The stent is placed into a blood vessel (coronary artery) supplying blood to the heart and helps to keep the coronary artery open. The current approval expands the indications for use to include treatment of a blocked coronary artery (chronic total occlusion).

Sangia Total PSA Test - P170037 The Sangia Total Prostate Specific Antigen (PSA) Test consists of a Cassette Assembly and a Sample Collector. The Sangia Total PSA Test is used as an aid in the diagnosis of prostate cancer. This new test is the first point-of-care test that can deliver PSA results near where the patient is being evaluated, for example at the doctor's office, instead of waiting for lab analysis. The test can be administered with a simple finger prick, and results are generated in less than 15 minutes. Prostate-specific antigen, or PSA, is a protein produced by cancerous, as well as noncancerous tissue in the the prostate gland. The PSA test measures the level of PSA in a man's blood.

MANTA Vascular Closure Device - P180025 The MANTA Vascular Closure Device is a system designed to close large puncture sites in one of the large vessels in the leg (femoral artery) following catheterization procedures. The system is a polymer component (toggle) attached to a collagen plug and a delivery system used to place the toggle-collagen plug implant.

M6-C™ Artificial Cervical Disc - P170036 The M6-C™ Artificial Cervical Disc is an implant (device) that replaces the function of a damaged or diseased disc of the neck in the spine (C3-C7). The M6-C™ contains a series of polymer (ultra-high molecular weight polyethylene) fibers wound in a specific pattern. The fiber is wound around a polymer (polycarbonate urethane) core and through the slots in two titanium alloy inner endplates. The two titanium alloy inner endplates are welded to two titanium alloy outer endplates. The endplates attach to the patient's spinal bone and the implant is designed to maintain the natural movement of the spine.

Barricaid® Anular Closure Device (ACD) - P160050 The Barricaid® Anular Closure Device (ACD), also referred to as “Barricaid," is an implant (device) inserted in the spinal bone (vertebrae) of the lower back to try to prevent another herniated discs (reherniation). The Barricaid is made of titanium and is attached to a polyester (polyethylene terephthalate or commonly referred to as PET) flexible woven polymer fabric mesh. The Barricaid is intended to close the hole in a patient's spinal bone (vertebrae) following a limited discectomy procedure in the lower back (L4-S1) after an initial herniated disc.

VENTANA PD-L1 (SP142) Assay - P160002/S009 This is a test done in a laboratory using samples from triple negative breast cancer patients which doctors use to see if patients have programmed cell death ligand (PD-L1) in their cancer.

MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System - P100009/S028 The MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System are two newer models of the MitraClip Clip Delivery System approved previously by the FDA. Each system contains a permanent implant that looks and functions like a clip. The clip is used to grasp the two leaflets of the mitral valve in the heart and clip them together to reduce the backflow of blood (called mitral regurgitation or MR). The current application expands the system’s indications for use to include secondary (or functional) MR, when MR is caused by a dysfunctional left ventricle, not by degeneration of the mitral valve itself.

VENOVO Venous Stent System - P180037 The VENOVO Venous Stent System is intended to treat a narrowed vein found in the upper pelvic region down to the groin area (iliofemoral vein). The VENOVO Venous Stent System has two components: a stent made of a nickel-titanium alloy (nitinol) tubing and an over-the-wire stent delivery catheter system.

OPTIMIZER Smart System - P180036 The OPTIMIZER Smart System includes an implantable pulse generator (IPG), a charging system and a programmer. The IPG monitors the heart’s activity and delivers non-excitatory electrical signals (cardiac contractility modulation therapy) to the right ventricle of the heart in patients with chronic heart failure. The charging system is used to recharge the IPG and the programmer to allows medical personnel to control the settings of the device.

COVERA™ Vascular Covered Stent - P170042/S002 The Covera™ Vascular Covered Stent is an expandable, flexible, metal (nitinol) tube-shaped device (stent) that is covered with a material called expanded polytetrafluoroethylene (ePTFE). Each covered stent is mounted on the end of a delivery catheter system. The device was previously approved for use in the treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arterio-venous (AV) access grafts only. In this PMA supplement, FDA approved this device for the treatment of a narrowing (stenosis) or blockage which has developed anywhere in the access circuit of patients on hemodialysis using an Arteriovenous (AV) Fistula.