Recently Approved Devices

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

The prodisc L Total Disc Replacement – P050010/S020 The prodisc® L Total Disc Replacement (prodisc® L) is intended to replace damaged intervertebral discs in a patient’s lower back (lumbar spine). The prodisc® L consists of three implant components; two metallic (cobalt-chrome) endplates and a plastic (ultra-high molecular weight polyethylene) inlay. This approval expands the indication for use of the prodisc® L to include treatment of up to two consecutive lumbar spinal sections (levels) from L3-S1.

Tack Endovascular System® (4F, 1.5-4.5mm) - P190027 The Tack Endovascular System® (4F, 1.5-4.5mm) is intended to repair a tear (dissection) in the inside lining of a blood vessel that may have occurred following a procedure (balloon angioplasty) to improve blood flow by widening a blocked or narrowed blood vessel in the leg below the knee. The Tack Endovascular System® (4F, 1.5-4.5mm) consists of four self-expanding “Tack” implants made of a nickel-titanium alloy (nitinol) and a delivery catheter system. The delivery catheter is a long, thin, tube-like device used to deliver the Tack(s) into the artery.

Inspire® Upper Airway Stimulation – P130008/S039 The Inspire® Upper Airway Stimulation (UAS) system is an implantable nerve stimulator used to treat moderate to severe obstructive sleep apnea (OSA). The Inspire® UAS system consists of implanted components including the implantable pulse generator (IPG), stimulation lead, and sensing lead and external components such as the physician programmer and the patient programmer. This approval expands the indications for use of the Inspire® UAS in patients between the ages of 18 and 21with moderate to severe OSA who: Do not have complete blockage of the upper airway; Are not able, or not effectively treated by, the removal of tonsils and other soft tissue behind the nose; Have been confirmed to fail, or cannot tolerate, PAP therapy despite attempts to improve compliance; Have followed standard of care in considering all other alternative/adjunct therapies.

The therascreen® BRAF V600E RGQ PCR Kit - P190026 The therascreen® BRAF V600E RGQ PCR Kit is a laboratory test doctors use to detect the V600E mutation in the BRAF gene in tumor tissue from patients with metastatic colorectal cancer. Identifying these mutations will help patients with metastatic colorectal cancer get personalized treatments that target these genetic changes. BRAFTOVI® (encorafenib) in combination with cetuximab are drugs used to treat patients with metastatic colorectal cancer.  The presence of BRAF V600E mutations in patients with metastatic colorectal cancer is associated with a response to treatment with BRAFTOVI® (encorafenib) in combination with cetuximab.  The therascreen® BRAF V600E RGQ PCR Kit helps doctors identify patients with metastatic colorectal cancer who should be treated with BRAFTOVI® (encorafenib) + cetuximab.

FoundationOne CDx - P170019/S013 FoundationOne® CDx (F1CDx) is a laboratory test designed to detect genetic variations in 324 genes, including FGFR2 gene variation, in tumor tissue. F1CDx is a companion diagnostic that was originally approved for the detection of genetic variations in patients who may be eligible for treatment with one of fifteen FDA-approved therapies for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, and ovarian cancer. This approval expands the indications for use of the F1CDx test to include bile duct cancer patients with genetic variationsin the FGFR2 gene. Identifying the genetic variations in FGFR2 will help patients with bile duct cancer get personalized treatment with PEMAZYRE® (pemigatinib).

TREO® Abdominal Stent-Graft System - P190015 The TREO® Abdominal Stent-Graft System is used to repair a weakened and bulging section (aneurysm) of the aorta (largest artery in the abdomen) below the renal arteries. The system consists of a tube-shaped implant (nitinol, polyester, and platinum-iridium) and a delivery catheter.

FoundationOne CDx - P170019/S011 FoundationOne® CDx (F1CDx) is a laboratory test designed to detect genetic variations in 324 genes, including the MET gene, in tumor tissue. F1CDx is a companion diagnostic that was originally approved for the detection of genetic variations in patients who may be eligible for treatment with one of fifteen FDA-approved therapies for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, and ovarian cancer. This approval expands the indications for use of the F1CDx test to include lung cancer patients with certain genetic mutations in the MET gene in tumor tissue who may benefit from treatment with TABRECTA® (capmatinib). Identifying these changes will help patients with lung cancer get personalized treatment with TABRECTA® (capmatinib).

Philips HeartStart FR3 Defibrillator, Primary Battery, Rechargeable Battery, Charger for the Rechargeable Battery, SmartPads III, DP pads, and Pediatric Key – P160028 The HeartStart FR3 Defibrillator is a battery-powered automated external defibrillator (AED). The HeartStart FR3 AED is indicated for use on people who have had a sudden loss of heart function (sudden cardiac arrest or SCA).

HeartStart FRx Defibrillator (861304), Primary Battery (Model M5070A), Aviation FRx Battery (989803139301), SMART Pads II (Model 989803139261), and Infant/Child Key (Model 989803139311) – P180028 The Philips HeartStart FRx Defibrillator (Model 861304) is a battery-powered automated external defibrillator (AED). The FRx AED is indicated for use on potential victims of sudden loss of heart function (sudden cardiac arrest or SCA).

FoundationOne CDx – P170019/S015 FoundationOne® (F1CDx) is a laboratory test designed to detect genetic variations in 324 genes and two genomic signatures in addition to homologous recombination repair (HRR) genes in tumor tissue. F1CDx is a companion diagnostic that was originally approved for the detection of genetic mutations in patients who may benefit from one of fifteen FDA-approved therapies for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, and ovarian cancer. This approval expands the indications for use of the F1CDx test to include prostate cancer patients with certain genetic mutations in the HRR genes. In prostate cancer, mutations in the HRR genes cause abnormal functioning of the HRR proteins resulting in defective homologous DNA repair. Identifying these genetic alterations will help prostate cancer patients to get personalized treatment with Lynparza (olaparib).

PD-L1 IHC 28-8 pharmDx - P150025/S013 The PD-L1 IHC 28-8 pharmDx is a lab test doctors can use to identify if patients with non-small cell lung cancer (NSCLC) have the protein called programmed cell death ligand 1 (PD-L1) in their cancer.  This lab test was previously approved to identify the PD-L1 protein in patients with non-squamous lung, urothelial, and head or neck squamous cell cancer for treatment with the drug, OPDIVO® (nivolumab). This approval expands the indications for use for this test for determining whether patients with NSCLC should be treated with the drugs, OPDIVO® (nivolumab) and YERVOY® (ipilimumab).

(no image available)   JUVÉDERM® VOLUMA™ XC – P110033/S047 JUVÉDERM® VOLUMA™ XC is a gel implant (dermal filler) that is injected into specific areas of facial tissue. It consists of crosslinked hyaluronic acid (HA) made by the Streptococcus species of bacteria, formulated to a concentration of 20 mg/mL with 0.3% of the drug lidocaine as a numbing agent.  This product was previously approved for injection into facial tissue to temporarily restore volume and fullness to the areas of the mid-face, which includes the cheeks and nearby regions confined to the middle portion of the face. This approval expands the use of this product to include the chin region.

FoundationOne®CDx – P170019/S016 FoundationOne®CDx (F1CDx) is a laboratory test designed to detect genetic variations in 324 genes in addition to select gene rearrangements and other biomarkers, such as tumor mutational burden (TMB), in the genomic makeup of a tumor. F1CDx is a companion diagnostic that was originally approved for the detection of genetic mutations in patients who may benefit from one of fifteen FDA-approved therapies for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, and ovarian cancer. This approval expands the indications for use of the F1CDx test to include solid tumor patients who have high tumor mutational burden (TMB). The TMB score comes from finding the number of mutations per megabase (length of a genome segment) in the tumor DNA. Identifying tumors with high levels of TMB will help patients with solid tumors get personalized treatment with KEYTRUDA® (pembrolizumab).

cobas® EZH2 Mutation Test – P200014 The cobas® EZH2 Mutation Test is a laboratory test designed to detect specific mutations in the EZH2 gene in tumor tissue taken from patients with follicular lymphoma. Identifying these mutations will help doctors identify patients with follicular lymphoma who should be considered for treatment with TAZVERIK™ (tazemetostat).

The Arctic Front Advance™ and Arctic Front Advance Pro™ and The Freezor Max™ Cardiac Cryoablation Catheters - P100010/S098 The Arctic Front Advance and Artic Front Advance Pro Cardiac Cryablation Catheters are balloon-tipped catheters that use cold energy to treat a condiction called atrial fibrillation (AF), which is an abnormal heart rhythm causing fast and irregular heartbeats. The Freezor Max Cardiac Cryoablation Catheter is a secondary catheter that also uses cold energy to treat areas of the heart that the balloon-tipped catheters can not reach. The CryoConsole is the source of the gas used to make both catheters cold. The FDA previously approved these catheters to treat patients with AF episodes that begin suddently and then stop on their own or with treatment within seven days (paroxysmal AF). This approval expands the indications for use to treat patients with AF episdoes that last for more than seven days but less than six months (persistent atrial fibrillation of less than six months duration). Compared with paroxysmal AF, persistent AF is often harder to treat.