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 15 July 2020Source: Diabetes &Metabolic Syndrome: Clinical Research &ReviewsAuthor(s): M.G. Rajanandh
Source: Diabetes and Metabolic Syndrome: Clinical Research and Reviews - Category: Endocrinology Source Type: research
Publication date: Available online 13 July 2020Source: Canadian Journal of DiabetesAuthor(s): Yiting Wang, Fang Liu
Source: Canadian Journal of Diabetes - Category: Endocrinology Source Type: research
Authors: Dourado M, Cavalcanti F, Vilar L, Cantilino A Abstract CKD has a high prevalence worldwide, mainly due to its main etiologies-diabetes and hypertension. It has high cardiovascular morbidity and mortality, with traditional risk factors such as atherosclerosis, hypertension, diabetes, smoking, and left ventricular hypertrophy being common. Nontraditional cardiovascular risk factors, such as anemia, hyperparathyroidism, chronic inflammation, and microalbuminuria, are also well studied. Prolactin is a hormone not only related to lactation but also being considered a uremic toxin by some authors. It accumulates...
Source: International Journal of Endocrinology - Category: Endocrinology Tags: Int J Endocrinol Source Type: research
Erratum to "Gastroenteropancreatic Neuroendocrine Neoplasia Characterization in Portugal: Results from the NETs Study Group of the Portuguese Society of Endocrinology, Diabetes and Metabolism". Int J Endocrinol. 2020;2020:9184324 Authors: Santos AP, Vinagre J, Soares P, Claro I, Sanches AC, Gomes L, Fernandes I, Catarino AL, Preto J, Pereira BD, Marques AP, Rodrigues F, Amaral C, Rocha G, Mellidez JC, Simões H, Lopes JM, Bugalho MJ, On Behalf Of The NETs Study Group Of The Portuguese Society Of Endocrinology Diabetes And Metabolism Abstract [This corrects the article DOI: 10.1155/2019/...
Source: International Journal of Endocrinology - Category: Endocrinology Tags: Int J Endocrinol Source Type: research
Conclusions: Maternal serum TG/HDL levels at late gestation are positively associated with neonatal body weight and the risk of macrosomia in women without DM. Maintaining maternal lipid levels in an appropriate range is important in the context of fetal overgrowth and primary prevention of macrosomia. PMID: 32655633 [PubMed]
Source: International Journal of Endocrinology - Category: Endocrinology Tags: Int J Endocrinol Source Type: research
Publication date: Available online 14 July 2020Source: Seminars in Cancer BiologyAuthor(s): Rui Caetano Oliveira, Henrique Alexandrino, Maria Augusta Cipriano, Filipe Caseiro Alves, José Guilherme Tralhão
Source: Seminars in Cancer Biology - Category: Cancer & Oncology Source Type: research
Source: Cancer Treatment Reviews - Category: Cancer & Oncology Source Type: research
This study aimed to explore the protective effects of Wenshen-Yanggan decoction on dopaminergic (DA) neuron injury in a rotenone-induced mouse model with chronic Parkinson's disease (PD) and explore its mechanism of action. Ultraperformance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) was used to measure the content of six main components in the Wenshen-Yanggan decoction. The chronic PD mouse model was established by treating 10-month-old healthy wild C57BL/6 male mice with rotenone 30 mg/kg/day for 28 days in succession. The pole test and rotarod test were applied to detect the rescue effect of Wensh...
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
This study was aimed at establishing the safety and effectiveness outcomes for patients with deranged liver panel treated with a Ghanaian finished polyherbal product. The product Heptonica is prepared by CPMR from three medicinal plants: Bidens pilosa, Citrus aurantifolia, and Trema orientalis. Fifty (50) participants with clinical and biochemical signs of liver impairment were purposively recruited and treated for a period of 28 days. Participants received Heptonica at a dose of 30 mL 8 hourly after meals for the treatment period. Clinical and biochemical evaluation (liver panel test, renal function test, haematolo...
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
Authors: Feng Z, Feng Z, Han J, Cheng W, Su B, Mo J, Feng X, Feng S, Chen G, Huang P, Huang L, Cui Z Abstract Shenling Baizhu additive powder (SLBZ-AP), a formulation of a variety of natural medicinal plants, has clinical efficacy in treating cancers in previous studies. We explored the effect of SLBZ-AP in bone metastasis of lung cancer (BMLC) mice, and the possible mechanism involved was further investigated in the present study. Mice model of BMLC was made and treated with SLBZ-AP. Pain behavioral tests were performed to explore the effect on BMLC-induced pain in mice. TUNEL staining was used to investigate apop...
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med 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