Recently Approved Devices

The FDA has recently approved the following devices to be marketed.

IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter - P190008 The IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (IN.PACT AV DCB) is a PTA balloon catheter that uses a drug-coated balloon to open a blocked or narrowed arteriovenous (AV) fistula. An AV fistula is a surgically created connection between an artery and vein used as an access site for hemodialysis treatment (removing waste from the blood of patients with kidney failure). The balloon is coated on its outer surface with the drug paclitaxel, a drug which may help prevent the vessel from narrowing again (restenosis).

LIAISON® XL MUREX Anti-HBc, LIAISON® XL MUREX Control Anti-HBc - P180038 This test is used with the LIAISON XL analyzer which runs the assay and analyzes the results. The LIAISON XL MUREX Control Anti-HBc is used as a quality control to ensure that the test is working properly.

LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs, LIAISON® XL MUREX Anti-HBs Verifiers - P180039 The LIAISON XL MUREX Anti-HBs is a laboratory test used to detect human antibodies against the hepatitis B virus (HBV) in a patient's blood. The presence of antibodies to a part of the HBV can help determine if a patient has been exposed to HBV or is immune to HBV, but will not be able to tell if a patient has a recent or a long-term  HBV infection, or if a patient has recovered from HBV infection. This test is used with the LIAISON XL analyzer which runs the assay and analyzes the results. The LIAISON XL MUREX Control Anti-HBs and the LIAISON XL MUREX Anti-HBs Verifiers are used to check that the test is working properly.

Abbott Medical Infinity DBS System - P140009/S039 The Abbott InfinityTM DBS Neurostimulation System is an implantable device that delivers low-intensity electrical pulses to nerve centers in the brain using different combinations of amplitude, pulse width, and frequency. This system consists of the following three components: A non-rechargeable, implantable pulse generator (IPG), a patient controller app, and a lead kit and extension kit. This supplement expands the indications for use of this device to include an additional option of lead implant location in the brain for patients with advanced levodopa-responsive Parkinson's disease that is not adequately controlled by medications.

Flow Re-Direction Endoluminal Device (FRED®) System - P180027 The FRED® System uses a permanent metal wire stent to provide support for a weakened area in a blood vessel in the brain that has bulged or ballooned into a brain aneurysm. The FRED® System blocks off blood flow to the aneurysm.

Bulkamid Urethral Bulking System - P170023 Bulkamid is a thick, permanent gel used to treat women who have stress urinary incontinence due to weak pelvic floor (urethral sphincter) muscles.  The Bulkamid Urethral Bulking System is a single-use kit that consists of sterile syringes filled with the Bulkamid gel, a rotatable sheath, and injection needles.

AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (IOL), AcrySof™ IQ Vivity™ Toric Extended Vision IOLs, AcrySof™ IQ Vivity™ Extended Vision UV Absorbing IOL, and AcrySof™ IQ Vivity™ Toric Extended Vision UV Absorbing IOLs - P930014/S126 The AcrySof™ IQ Vivity™ IOLs are artificial lenses implanted in the eye of adult patients to correct vision after having the lens removed due to a cataract. Cataracts are often the result of aging, but can have other causes. This approval expands the use to improve how well you are able to see during activities that take place: At an arm’s length distance such as working on a computer, applying makeup, or shaving (intermediate vision), and at close range, such as reading, writing, and sewing (near vision).

Ventana Medical Systems CINtec PLUS Cytology - P190024 CINtec® PLUS Cytology is a laboratory test doctors can use to detect proteins, called p16 and Ki67, in Pap test specimens obtained from women that have the human papilloma virus (HPV). The doctor uses the results of the HPV test and the CINtec® PLUS Cytology test to make treatment decisions.

Alto™ Abdominal Stent Graft System - P120006/S031 The Alto™ Abdominal Stent Graft System is intended to repair a weakened and bulging section (aneurysm) of the aorta (largest part of the abdomen) below the renal arteries (infrarenal abdominal aorta).  The system consists of the implant, extension implants, and delivery catheter. This supplement includes changes made to the implant and delivery system design for the Ovation Abdominal Stent Graft System.

Nucleus 24 Cochlear Implant System - P970051/S172 The Nucleus 24 Cochlear Implant System is an implant that provides the user with hearing sensation through electrical stimulation of the hearing nerve (auditory nerve). The system consists of an internal and an external component. The Nucleus 24 Cochlear Implant System was previously approved for use in patients ages 12 months and older. This approval expands the indications of use of this device to include children 9 to 12 months of age who have profound sensorineural hearing loss (SNHL) in both ears.

VENOUS WALLSTENT - P980033/S050 The VENOUS WALLSTENT is intended to treat a narrowed vein found in the upper pelvic region down to the groin area (iliofemoral vein). The VENOUS WALLSTENT has two components: a stent made from braided metallic (elgiloy) wire and an over-the-wire stent delivery catheter system.  It was previously approved to increase the width of a narrowed section of the central veins. This approval expands the indications for use of the VENOUS WALLSTENT to increase the width of the narrowed section of the iliofemoral vein.

The cobas HPV for use on the cobas 6800/8800 Systems - P190028 The cobas HPV for use on the cobas 6800/8800 Systems (cobas HPV) is a laboratory test designed to detect human papillomavirus (HPV) in cervical samples. The cobas HPV consists of the cobas 6800/8800 Systems, cobas HPV analysis software, and chemical substances (reagents) that are used to prepare the cervical samples and for chemical analysis.The test is programmed only for use on the cobas 6800 or 8800 System. The cobas 6800/8800 software processes the data and assigns positive, negative or invalid test results which can be reviewed directly on the system screen, exported, or printed as a report.