Recently Approved Devices

The FDA recently approved the following devices to be marketed.

Minimally Invasive Deformity Correction (MID-C) System - H170001 The Minimally Invasive Deformity Correction (MID-C) System is a non-fusion spinal device intended to prevent spinal curve progression in adolescent patients with idiopathic scoliosis. The MID-C System includes a ratcheting rod made from titanium alloy components that is attached to the spine using screws.

BAROSTIM NEO System - P180050 The BAROSTIM NEO System includes an implantable pulse generator (IPG), a carotid sinus lead kit and a programmer. The IPG delivers electrical signals to the body's pressure sensors (baroreceptors) in patients with advanced heart failure. The programmer allows medical personnel to control the settings of the device.

The Tether™ - Vertebral Body Tethering System - H190005 The Tether™ - Vertebral Body Tethering System is a non-fusion spinal device intended to treat idiopathic scoliosis, an abnormal curvature in the spine that occurs without a known cause, in young patients whose bones have not fully matured. The Tether™ - Vertebral Body Tethering System is made up of: anchors, bone screws, cord, and set screws. The anchors, bone screws and set screws are made out of titanium alloys that are commonly used as spine implants. The cord is made of a strong flexible polymer, SULENE® PET (polyethylene-terephthalate).

Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System - P130021/S058 The Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System each consists of a transcatheter aortic valve (TAV), a delivery catheter, and a loading system. The TAV is an artificial heart valve made of pig tissue attached to a flexible, self-expanding nickel-titanium (Nitinol) frame for support. This approval expands the indications for use for both to patients at low risk for surgical therapy.

Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System - P140031/S085 The Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System and Edwards SAPIEN 3 Ultra THV System each consists of a catheter-based artificial aortic heart valve and accessories used to implant the valve without open-heart surgery. The valve is made of cow tissue attached to a balloon-expandable, cobalt-chromium frame for support. This approval expands the indications for use for both to patients at low risk for surgical therapy.

PD-L1 IHC 22C3 pharmDx - P150013/S016 The PD-L1 IHC 22C3 pharmDx is a laboratory test doctors can use to identify the protein programmed cell death ligand 1 (PD-L1) in tumor tissue obtained from patients who have esophageal squamous cell cancer. This lab test was previously approved to identify the PL-L1 tumor in patients with lung, gastric, urothelial, cervical and head and neck cancer.  This approval expands the indications for use for this test for determining whether patients with esophageal squamous cell cancer are eligible for treatment with the medicine KEYTRUDA® (pembrolizumab).

MED-EL Cochlear Implant System - P000025/S104 The MED-EL Cochlear Implant System is intended to produce auditory sensations by providing electric stimulation in the cochlea. This approval expands the current cochlear implantation indications to include patients 5 years and older with single sided deafness (SSD) and asymmetric hearing loss (AHL) who have profound sensorineural hearing loss in the ear to be implanted and normal hearing or mild to moderate sensorineural hearing loss in the other ear.

Medtronic CoreValve System; Medtronic CoreValve Evolut R System; Medtronic CoreValve Evolut PRO System - P130021/S033 The Medtronic CoreValve family of devices is comprised of three design iterations: the Medtronic CoreValve System (1st generation), the Medtronic CoreValve Evolut R System (2nd generation); Medtronic CoreValve Evolut PRO System (3rd generation). Each system consists of a transcatheter aortic valve (TAV), a delivery catheter, and a loading system. The TAV is an artificial heart valve made of pig tissue attached to a flexible, self-expanding nickel-titanium (Nitinol) frame for support. This approval expands the indications for use to patients at intermediate risk for surgical therapy.

PD-L1 IHC 22C3 pharmDx - P150013/S014 The PD-L1 IHC 22C3 pharmDx  is a lab test doctors use to see if patients who have head and neck squamous cell cancer have programmed cell death ligand 1 (PD-L1) in their cancer. This lab test was previously approved to identify the PD-L1 tumor in patients with lung, gastric, cervical and urothelial cancer for treatment with KEYTRUDA®. This approval expands the indications for use for this test for determining whether patients with head or neck squamous cell cancer are eligible for treatment with the medicine KEYTRUDA® (pembrolizumab).

HeartStart OnSite Defibrillator (Model M5066A), HeartStart Home Defibrillator (Model M5068A), Primary Battery (Model M5070A), SMART Pads Cartridges (Adult Model M5071A) and Infant/Child (Model M5072A) - P160029 The HeartStart OnSite (M5066A) and HeartStart Home (M5068A) are automatic external defibrillators (AED) designed to treat people experiencing sudden cardiac arrest (SCA), a medical condition in which the heart suddenly and unexpectedly stops beating.

Eversense Continuous Glucose Monitoring System - P160048/S006 The Eversense Continuous Glucose Monitoring System is a prescription device that provides real-time glucose monitoring every five minutes for up to 90 days at a time for people with diabetes. The system consists of an implantable fluorescence-based sensor, a smart transmitter, and a mobile app for displaying glucose values, trends and alerts on the patient's compatible mobile device (smart phone, tablet, etc.). This supplement expands the indications for the Eversense CGM system to allow for replacement of fingerstick blood glucose testing for diabetes treatment decisions.

Hintermann Series H3™ Total Ankle Replacement System - P160036 The Hintermann Series H3™ Total Ankle Replacement System is an implanted medical device intended to replace a painful arthritic ankle joint in the first surgical treatment for the joint (primary surgery).

TransMedics OCS Lung System - P160013/S002 The TransMedics OCS Lung System is designed to preserve donor lungs prior to transplantation. The TransMedics OCS Lung System includes a portable enclosure with mechanical and electrical components used to warm, ventilate and perfuse the lungs (i.e., supply with fluid), as well as a lung preservation solution combined with packed red blood cells. Prior to transplantation, the device enables the transplant team to monitor and assess the donor lungs while they are being perfused. This approval expands the indications for use to include preservation of donor lung pairs initially deemed unacceptable for transplantation based on limitations of cold storage preservation.

therascreen PIK3CA RGQ PCR Kit - P190001 and P190004 The therascreen® PIK3CA RGQ PCR Kit is a laboratory test doctors use to detect 11 mutations in the PIK3CA gene in tumor tissue or in the colorless fluid part of blood (plasma) from patients with advanced or metastatic breast cancer.  In breast cancer tissue, mutations in the PIK3CA gene causes an altered form of the PIK3CA protein and result in abnormal functioning of the protein. Identifying these mutations will help patients with breast cancer get a personalized treatment that target these genetic changes.