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...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

Related Links:

by Christian Sinclair (@ctsinclair)We used to publish a lot more article reviews here on Pallimed. Sometimes the analysis would be quite deep and sometimes we would just lump together a while bunch of snippets from key articles. I have been keeping an ever-growing list of articles I would love to write up for the site*, but never seemed to have the time to get to them, and then new ones would come out, that I would want to write about, but they too would just get added to the list. At the end of the year, I would look back on key articles for our field and be pretty bummed out that I never got anything published here about...
Source: Pallimed: A Hospice and Palliative Medicine Blog - Category: Palliative Care Tags: meta sinclair Source Type: blogs
This study determined if there are observable patient-, tooth- and crack-level characteristics markedly associated with whether a tooth with an external crack also has an internal crack. METHODS: Two hundred nine dentists in The National Dental Practice-Based Research Network enrolled 2,858 adults with a vital permanent posterior tooth having at least 1 observed external crack. Presence and characteristics of internal cracks were recorded for 435 cracked teeth that were treated. Generalized estimating equations were used to identify significant (P
Source: Journal of the American Dental Association - Category: Dentistry Tags: J Am Dent Assoc Source Type: research
Researchers at the University of Guelph in Ontario, Canada claim the whey and casein proteins in cow's milk make people feel full and release hormones which reduce blood sugar.
Source: the Mail online | Health - Category: Consumer Health News Source Type: news
DIABETES type 2 symptoms can be hard to spot and many people with the condition won ’t realise they have it. But if this type of diabetes is left untreated it can lead to more serious health problems. Drinking certain types of alcohol can cause blood sugar levels to spike.
Source: Daily Express - Health - Category: Consumer Health News Source Type: news
Xiuqing Ji, Qiong Pan, Yan Wang, Yun Wu, Jing Zhou, An Liu, Fengchang Qiao, Dingyuan Ma, Ping Hu, Zhengfeng Xu
Source: Frontiers in Genetics - Category: Genetics & Stem Cells Source Type: research
In an intriguing study, black patients were far more likely to agree to certain health tests if they discussed them with a black male doctor.
Source: NYT Health - Category: Consumer Health News Authors: Tags: Preventive Medicine Blacks Race and Ethnicity Vaccination and Immunization Doctors Diabetes Heart Oakland (Calif) Source Type: news
CONCLUSION: Having a spouse who is depressed may increase one's risk of cognitive decline as well as one's risk of depression. Interventions for preventing cognitive decline and depression among older adults may be enhanced by considering the marital context. PMID: 30120019 [PubMed - as supplied by publisher]
Source: The American Journal of Geriatric Psychiatry - Category: Psychiatry Tags: Am J Geriatr Psychiatry Source Type: research
ConclusionOur study revealed that early and multiple doses of systemic baicalein attenuated neuropathic pain and improved sciatic nerve function by inhibiting pro-inflammatory cytokine expression and attenuating the activation of astrocytes in the spinal cord.
Source: Journal of the Chinese Medical Association - Category: General Medicine Source Type: research
Authors: Urdaneta J, Arroyo D, Mon C, Abadal J, Gálvez E, Ortiz M, Camacho R, Herrero JC PMID: 30119947 [PubMed - as supplied by publisher]
Source: Nefrologia : publicacion oficial de la Sociedad Espanola Nefrologia - Category: Urology & Nephrology Tags: Nefrologia Source Type: research
A new study evaluates the management of emergency situations in patients with chronic adrenal insufficiency.Clinical Endocrinology
Source: Medscape Today Headlines - Category: Consumer Health News Tags: Diabetes & Endocrinology Journal Article Source Type: news
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