Medtech approvals: FDA releases December 2015 PMAs

The Food &Drug Administration today released a list of pre-market approvals granted in December 2015: Summary of PMA Originals &Supplements Approved Originals: 2 Supplements: 81 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: 599 Total Active: 423 Total On Hold: 176 Summary of All PMA Submissions Originals: 3 Supplements: 92 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 81 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 163.1 FDA Time: 140.4 Days MFR Time: 22.7 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, &ZIP DEVICE DESCRIPTION / INDICATIONS P140030 12/17/15 Astron Peripheral Self-Expanding Nitinol Stent System Biotronik, Inc. Lake Oswego, OR 97035 Approval for the Astron Peripheral Self-Expanding Stent System. This device is indicated for improving luminal diameter in patients with iliac atherosclerotic lesions in vessel reference diameters between 4.3mm and 9.5mm and lesion lengths up to 105mm. P150019 12/7/15 Paradigm Real-Time Revel System Medtronic MiniMed Northridge, CA 91325 Approval for the Paradigm Real-Time Revel System. This device is indicated for: Paradigm REAL-Time Revel insulin pump.  The Paradigm REAL-Time Revel insulin pumps (MMT-523/MMT-723) are indicated for the continuous delivery of insulin...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

Related Links:

Conclusions: Evidence indicated effective ultrasound irradiation against immature mosquitoes in the water. This study provides a clear scientific basis for larvicidal properties induced by ultrasound emissions at laboratory conditions. The findings could be used for setting the ultrasound devices in the field investigations for achieving desired effectiveness. PMID: 32228339 [PubMed - as supplied by publisher]
Source: International Journal of Radiation Biology - Category: Radiology Tags: Int J Radiat Biol Source Type: research
Publication date: Available online 1 April 2020Source: Journal of Molecular LiquidsAuthor(s): Xianting Xie, Lu Zhang, Wenjuan Zhang, Reza Tayebee, Atefe Hoseininasr, Hamid H. Vatanpour, Zeinab Behjati, Suying Li, Marjan Nasrabadi, Liuyi Liu
Source: Journal of Molecular Liquids - Category: Molecular Biology Source Type: research
Publication date: Available online 1 April 2020Source: Carbohydrate PolymersAuthor(s): Chia-Hsiang Yen, Sheng-Tien Li, Nai-Chen Cheng, You-Ren Ji, Jyh-Horng Wang, Tai-Horng Young
Source: Carbohydrate Polymers - Category: Biomedical Science Source Type: research
Publication date: Available online 1 April 2020Source: Inorganica Chimica ActaAuthor(s): Sourav De, S.K. Ashok Kumar
Source: Inorganica Chimica Acta - Category: Chemistry Source Type: research
Publication date: Available online 1 April 2020Source: European Polymer JournalAuthor(s): Himani Kalita, Manoj Patowary
Source: European Polymer Journal - Category: Chemistry Source Type: research
Phys. Chem. Chem. Phys., 2020, Accepted Manuscript DOI: 10.1039/D0CP00645A, PaperKrishan Kumar, Navin Kumar Kumar Mogha, Ritu Yadav, Pannuru Venkatesu Synthesizing and understanding phase transition behavior of novel block copolymers is very crucial for fabricating next generation of smart materials with foreseeable applications. In this regard, we synthesized three random... The content of this RSS Feed (c) The Royal Society of Chemistry
Source: RSC - Phys. Chem. Chem. Phys. latest articles - Category: Chemistry Authors: Source Type: research
Publication date: Available online 2 April 2020Source: Journal of Environmental SciencesAuthor(s): Oscar M. Rodríguez-Narvaez, Ruwini D. Rajapaksha, Mahinda I. Ranasinghe, Xuelian Bai, Juan M. Peralta-Hernández, Erick R. Bandala
Source: Journal of Environmental Sciences - Category: Environmental Health Source Type: research
Authors: Park SH, Lee MS, Kim SR, Kwak YG Abstract BACKGROUND: Healthcare personnel (HCP) are at risk of being exposed to or transmitting infections in hospitals, and vaccination against vaccine-preventable diseases (VPDs) is a well-known preventive strategy. Vaccination against influenza, hepatitis B virus, measles-mumps-rubella, varicella, and pertussis is recommended for HCP. However, there is no information on the current status of hospitals' vaccination policies for HCP in Korea. METHODS: We conducted a nationwide survey on hospital vaccination policies and barriers to implementing recommended vaccination ...
Source: Journal of Korean Medical Science - Category: Biomedical Science Tags: J Korean Med Sci Source Type: research
Publication date: Available online 2 April 2020Source: Journal of Photochemistry and Photobiology B: BiologyAuthor(s): Seraj Bahman, Ghadimi Sara, Hosseini Somayeh, Tamiz Parvin, Katayoun A.M. Kalhori, Sohrabi Mona, Fekrazad Reza
Source: Journal of Photochemistry and Photobiology B: Biology - Category: Speech-Language Pathology Source Type: research
The coronavirus has been a far deadlier threat in New Orleans than the rest of the United States, with a per-capita death rate much higher than in New York City.Reuters Health Information
Source: Medscape Critical Care Headlines - Category: Intensive Care Tags: Diabetes & Endocrinology News Source Type: news
More News: Acetaminophen | Angioplasty | Astigmatism | Audiology | Back Pain | Baloon Angioplasty | Biotechnology | Bladder Cancer | Bone Graft | Brain | Brain Cancers | Burns | Calcium | Cancer | Cancer & Oncology | Cardiology | Cardiovascular & Thoracic Surgery | Carotid Angioplasty | Computers | Contracts | Deep Brain Stimulation | Diabetes | Diabetes Mellitus | Electrocardiogram | Endocrinology | Environmental Health | Genetics | Health | Heart | Heart Transplant | Heart Valve Disease | Heart Valve Surgery | Heart Valves | Hepatitis | Hepatitis C | HIV AIDS | Insulin | Laboratory Medicine | Laparoscopy | Laser Surgery | Lortab | Medical Devices | Men | Myopia (short sighted) | Neurology | Neuroscience | Neurosurgery | Opthalmology | Orthopaedics | Osteoarthritis | Pain | Pain Management | Peripheral Angioplasty | PET Scan | Radiography | Skin | Skin Graft | Spondylolisthesis | Statistics | Study | Vagus Nerve Stimulation Therapy | Warnings