Medtech approvals: FDA releases June 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in June 2015: Summary of PMA Originals &Supplements Approved Originals: 5 Supplements: 80 Summary of PMA Originals Under Review Total Under Review: 53 Total Active: 22 Total On Hold: 31 Summary of PMA Supplements Under Review Total Under Review: 575 Total Active: 418 Total On Hold: 157 Summary of All PMA Submissions Originals: 4 Supplements: 72 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 80 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 115.2 FDA Time: 97.1 Days MFR Time: 18.1 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, &ZIP DEVICE DESCRIPTION / INDICATIONS P120024 6/11/15 activL® Artificial Disc Aesculap Implant Systems, LLC Center Valley, PA 18034 Approval for the activL® Artificial Disc. This device is indicated for reconstruction of the disc at one level (L4-L5 or L5- S1) following single-level discectomy in skeletally mature patients with symptomatic degenerative disc disease (DDD) with no more than Grade I spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. The activL® Artificial Disc is implanted using an anterior retroperitoneal approach. Patients receiving the activL® Arti...
Amie L. Severino, Arash Shadfar, Joshua K. Hakimian, Oliver Crane, Ganeev Singh, Keith Heinzerling, Wendy M. Walwyn
DIABETES type 2 symptoms include weight loss, tiredness and passing more urine than normal. You can prevent high blood sugar with exercise and a healthy diet - these are the best tips for getting active with diabetes.
A new Dundee University ultrasound process offers a more accurate diagnosis of the disease.
FIBROMYALGIA causes widespread pain, poor sleep quality and fatigue. The exact cause of the condition is unknown, but experiencing a stressful event, sleep problems and chemical imbalances may be factors. Sufferers can treat the symptoms through trying these exercises.
When it comes to studying the genetics of the brain, Soo-Kyung Lee is a star, yet she was stunned to discover the cause of her daughter ’ s devastating disabilities.
PROSTATE cancer kills over 11,000 men in the UK each year. But a new, non-invasive ultrasound can diagnose it in just 15 minutes, researchers at Dundee University have announced.
HIGH blood pressure symptoms include a severe headache, fatigue and chest pain. If left untreated it can cause more dangerous health complications, such as heart attacks and strokes. Luckily, the high levels can be brought down by eating different fruits and vegetables, such as celery.
In the most detailed study of its type, researchers demonstrate that artificial sweeteners damage blood vessels and may increase diabetes risk.
A new study suggests that the standard body mass index cannot accurately predict someone's risk of developing type 2 diabetes or prediabetes.
INTRODUCTION: Suicidal behavior is strongly associated with depression in major depressive (MDD) and bipolar (BD) disorders, especially with associated behavioral activation, dysphoria, or agitation. A rare intervention with evidence of suicide risk-reduci...
More News: Allergy | Angioplasty | Aortic Stenosis | Audiology | Back Pain | Baloon Angioplasty | Bipolar | Brain | Breast Augmentation | Breast Carcinoma | Cancer & Oncology | Carbidopa/Levodopa | Carcinoma | Cardiology | Cardiovascular | Cardiovascular & Thoracic Surgery | Cervical Discectomy | Chemistry | Colposcopy | Costa Rica Health | Cytology | Deep Brain Stimulation | Dermatology | Diabetes | Diabetes Mellitus | Dialysis | Disability | Endocrinology | Endometrial Cancer | Endovascular Coiling | Environmental Health | Gastric (Stomach) Cancer | Gastroenterology | Genital Warts | Heart | Heart Disease | Heart Transplant | Heart Valve Disease | Heart Valve Surgery | Heart Valves | Hepatitis | Hepatitis C | HPV Testing | Human Papillomavirus (HPV) | Insulin | Laboratory Medicine | Laser Surgery | Lithium | Lung Transplant | Lymphoma | Mania | Medical Devices | Medical Ethics | Neurology | Neuroscience | Neurosurgery | Non-Small Cell Lung Cancer | Operative Vaginal Delivery | Opthalmology | Orthopaedics | Pain | Pain Management | Pediatrics | Penile Cancer | Peripheral Angioplasty | Plastic Surgery | Profits and Losses | Radiography | Spondylolisthesis | Study | Ultrasound | Vagus Nerve Stimulation Therapy | Warnings | Women