Medtech approvals: FDA releases October 2015 PMAs

The FDA today released its list of the pre-market approvals it granted for medical devices in October 2015: Summary of PMA Originals &Supplements Approved Originals: 9 Supplements: 133 Summary of PMA Originals Under Review Total Under Review: 58 Total Active: 32 Total On Hold: 26 Summary of PMA Supplements Under Review Total Under Review: 597 Total Active: 433 Total On Hold: 164 Summary of All PMA Submissions Originals: 7 Supplements: 74 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 133 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 161.5 FDA Time: 97.9 Days MFR Time: 63.6 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, &ZIP DEVICE DESCRIPTION / INDICATIONS P150003 10/2/15 SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation Maple Grove, MN 55311 Approval for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System. This device is indicated for improving luminal diameter in patients with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter in lesions ≤34 mm in length. P150013 10/2/15 PD-L1 IHC 22C3 pharmDx Dako North America, Inc. Carpinteria, CA 93013 Approval for the PD-L1 IHC 22C3 pharmDx. This device is...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

Related Links:

Publication date: Available online 17 March 2019Source: Gynecologic Oncology ReportsAuthor(s): Roberta Villa, Jacopo Azzollini, Bernard Peissel, Siranoush ManoukianAbstractBackgroundMayer-Rokitansky-Kuster-Hauser syndrome (MRKHS) is a congenital disorder of yet unknown etiology, characterized by agenesis/hypoplasia of the müllerian duct system. The occurrence of ovarian cancer (OC) in MRKHS is rare, with
Source: Gynecologic Oncology Reports - Category: OBGYN Source Type: research
Chemotherapy overdose may be avoided in obese patients with breast cancer using a tailored dosing strategy.Annals of Oncology
Source: Medscape Today Headlines - Category: Consumer Health News Tags: Hematology-Oncology Journal Article Source Type: news
A new study aims to elucidate the link between PCSK9 inhibitors and glucose metabolism. Might they increase the risk of diabetes, as statins have been shown to do?European Heart Journal
Source: Medscape Today Headlines - Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news
A new study examines the tissue-specific contribution to insulin sensitivity in hepatitis C. Does insulin sensitivity improve with viral eradication?Clinical Endocrinology
Source: Medscape Today Headlines - Category: Consumer Health News Tags: Diabetes & Endocrinology Journal Article Source Type: news
A better understanding of the evolution of brown adipose tissue may have important implications for the battle against modern obesity.Journal of the Endocrine Society
Source: Medscape Today Headlines - Category: Consumer Health News Tags: Diabetes & Endocrinology Journal Article Source Type: news
Despite the availability of highly effective direct-acting antiviral therapeutic regimens, many barriers to HCV eradication persist.Liver International
Source: Medscape Today Headlines - Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news
DIABETES type 2 symptoms can include unexplained weight loss, feeling very tired, and passing more urine than normal. But you could also be at risk of high blood sugar if you have this one sexual sign. Should you check your blood sugar levels?
Source: Daily Express - Health - Category: Consumer Health News Source Type: news
Chiara Mandoj, Luigi Tomao, Laura Conti
Source: Frontiers in Neurology - Category: Neurology Source Type: research
Yanlong Jia, Zhiwei Shen, Guisen Lin, Tingting Nie, Tao Zhang, Renhua Wu
Source: Frontiers in Neurology - Category: Neurology Source Type: research
Background: Nonalcoholic fatty liver disease (NAFLD) is common among people living with HIV. There are limited data available on the pathophysiology of NAFLD and the development of fibrosis in this population. Objectives: The aim of this study was to investigate the association of bacterial translocation, adipose tissue dysfunction, monocyte activation and gut dysbiosis in patients with HIV monoinfection and NAFLD. Methods: Cases with biopsy-proven NAFLD and HIV monoinfection were age and sex-matched to HIV-positive and HIV-negative controls. Markers of bacterial translocation [lipopolysaccharide-binding protein (L...
Source: AIDS - Category: Infectious Diseases Tags: BASIC SCIENCE Source Type: research
More News: Alcoholism | Allergy | Angioplasty | Aortic Stenosis | Astigmatism | Audiology | Baloon Angioplasty | Bipolar | Bone Graft | Brain | Brain Cancers | Breast Needle Aspiration | Cancer | Cancer & Oncology | Cancer of the Uterus | Cardiology | Cardiovascular & Thoracic Surgery | Cervical Cancer | Chemistry | Chemotherapy | Computers | Contracts | Deep Brain Stimulation | Dermatology | Dexamethasone | Diabetes | Diabetes Mellitus | Endocrinology | Endometrial Cancer | Environmental Health | Health | Health Management | Heart | Heart Disease | Heart Transplant | Heart Valve Disease | Heart Valve Surgery | Heart Valves | Hepatitis | Hepatitis B | Hepatitis C | Incontinence | Insulin | Laboratory Medicine | Laser Surgery | Liver | Liver Disease | Liver Transplant | Lung Cancer | Lung Transplant | Mania | Marketing | Medical Devices | Medical Ethics | Men | Middle East Health | Molecular Biology | Nanotechnology | Neurology | Neuroscience | Neurosurgery | Non-Small Cell Lung Cancer | Operative Vaginal Delivery | Penile Cancer | Peripheral Angioplasty | Radiation Therapy | Skin | Skin Graft | Study | Temodar | Ultrasound | Urology & Nephrology | Vagus Nerve Stimulation Therapy | Warnings