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PMA in Medical News

U.S. Foodservice Cites Critical Need for Food Safety Culture From Farm to Fork During Monterey PMA Conference

MONTEREY, Calif., July 27 /PRNewswire/ -- Providing the safest fresh fruit and vegetables to consumers takes proactive measures to limit contamination at every stage of the supply chain according to the chief food safety executive for U.S. Foodservice, one of the country's leading f...

Emphasys Medical Announces PMA Submission for Bronchial Valve Therapy

- Data from Positive VENT Trial Presented at ERS 17th Annual Congress - REDWOOD CITY, Calif., Oct. 1 /PRNewswire/ -- Emphasys Medical Inc. today announced the submission of a pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) requesting regulatory approval to ...

Hologic Announces Third Quarter Fiscal 2009 Operating Results

...essment exams in the U.S. FDA Approval of our Adiana Permanent Contraception System: On July 6, 2009, the FDA approved the Company's pma application for our Adiana Permanent Contraception System. The Adiana system is designed to provide women a minimally-invasive, non-incision alternati...

STAAR Surgical Generates Cash From Operations During Second Quarter

.... Caldwell continued. "The FDA's decision to remove the integrity hold that halted scientific review of our Visian Toric ICL means that review of our pma supplement has resumed. In addition, we are making progress in the regulatory process towards the approval of the Visian ICL and Visian Toric ICL in ...

Review of STAAR's Application for the Visian(R) Toric Implantable Collamer(R) Lens by FDA to Resume

...lamer Lens (TICL(TM)) for Myopic/Astigmatic patients. This application is a pma Supplement to the Visian ICL which the FDA approved on December 22, 2005. ...dard will be applied to the next subsequent submission for a 510(k), IDE or pma sent to the FDA by the Company. We believe the outstanding clinical result...

Review of STAAR's Application for the Visian(R) Toric Implantable Collamer(R) Lens by FDA to Resume

...lamer Lens (TICL(TM)) for Myopic/Astigmatic patients. This application is a pma Supplement to the Visian ICL which the FDA approved on December 22, 2005. ...dard will be applied to the next subsequent submission for a 510(k), IDE or pma sent to the FDA by the Company. We believe the outstanding clinical result...

AbbeyMoor Medical Receives FDA Approval for Design Improvements to The Spanner(TM) Prostatic Stent

... Inc., a developer and manufacturer of medical devices for the management and treatment of prostatic obstruction, announced today that it has received pma approval from the US Food and Drug Administration (FDA) for design changes to their flagship product, The Spanner(TM) Prostatic Stent. "These cha...

Sofinnova Partners Leads Investment Round in CoAxia

...ith Sofinnova's experience in financing medical device companies to successful exits, we believe that we are now well positioned for trial completion, pma submission and initiation of sales and marketing." Sofinnova, since its founding in 1972, has had a strategy to fund medical device and biopharma...

Neovasc Inc. Reports First Quarter 2009 Financial Results

...ared to $621,745 for the same period of 2008, an increase of 41%. The final pma submission to the U.S. Food and Drug Administration in March 2009 for the G...t March 31, 2009 for expenses related to the filing of the Metricath Gemini pma submission. Net cash used in investing activities was $7,971 for the three ...

Pulmonx Acquires Assets of Emphasys Medical and Unveils Combined Product Portfolio at International Conference of the American Thoracic Society (ATS) Annual Meeting

...se in the United States. 510(k) clearance is pending for the Chartis System. For more information visit www.pulmonx.com . (1) Emphasys Medical pma P070025 Panel Presentation, December 5, 2008, link: http://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4405s1-03.pdf (2) Aljuri N, Freitag ...
PMA in Medical Technology

Imaging Diagnostic Systems Updates PMA Filing Status for the New CT Laser Breast Imaging System

Secures 10th U.S. Clinical Site FORT LAUDERDALE, Fla., Nov. 27 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., (OTC Bulletin Board: IMDS) a pioneer in laser optical breast imaging, announced today that the Company has secured its 10th U.S. clinical site to parti...

CoAxia, Inc. Announces $21.5M Series D Financing

...g and Clinical Trial Progress Position Company for pma Submission MINNEAPOLIS, June 22 /PRNewswire/ ...enrollment expected to conclude in early 2010, and pma submission later that year. Also, the company anno...t we are now well positioned for trial completion, pma submission and initiation of sales and marketing."...

Pivotal Data Show Bronchial Thermoplasty Can Improve Quality of Life and Reduce Asthma Attacks and Emergency Room Visits for Adults with Severe Asthma

...otal study have enabled Asthmatx to submit a Premarket Approval application (PMA) to the FDA for regulatory approval. The FDA granted the Alair System pma Expedited Review Status in October 2008, based on its potential "to treat asthma, a life-threatening/debilitating disease" and because the "Alair Syst...

Midwest Research Institute Launches Clinical Molecular Diagnostics Laboratory

...ory offers dedicated facilities and staff committed to support molecular diagnostics assay developers with clinical trials and clinical validation for pma and 510k submission to the Food and Drug Administration. Specific services that MRI will provide include: Molecular diagnostic as...

Boston Scientific Submits Final Modules to FDA for Approval of Second-Generation Small Vessel and Long Lesion Stents

...ent is designed to be the first 38 mm drug-eluting stent available in the U.S. and will further expand the Company's leading DES portfolio. These pma submissions include clinical data from the global, multi-center TAXUS ATLAS Small Vessel (SV) and Long Lesion (LL) studies, designed to compare the pe...

Study Shows EUFLEXXA(R) Patients Report Significant Improvements in Osteoarthritis of the Knee Pain over a Six Month Period

...s not derived from an avian source (chicken or rooster combs), the risk of reactions related to avian proteins is eliminated.(2-7) EUFLEXXA received pma approval from the U.S. Food and Drug Administration (FDA) on December 3, 2004, and became available to the public on November 8, 2005. For more inform...

Echo Therapeutics Initiates Clinical Study of Its Symphony(TM) Transdermal Continuous Glucose Monitoring System in Patients with Type 1 and Type 2 Diabetes

...involves, among other factors, successfully completing pilot and pivotal clinical trials and obtaining a premarket approval, or PMA, from the FDA. The pma process requires Echo to prove the safety and efficacy of its tCGM system to the FDA's satisfaction. This process can be expensive and uncertain, and ...

Globus Medical Completes Enrollment Of SECURE(R)-C Cervical Artificial Disc Clinical Trial

...gators and staff as their contributions have been critical to successful completion of enrollment. We look forward to continued patient follow-up, and pma submission for ultimate market entry within the next two years." Globus plans to initiate two more US IDE clinical trials this year on motion preser...

Clinical Data Demonstrates 5-Year Efficacy and Safety of Aquamid(R) in Facial Augmentation

...tic treatment of facial wrinkles/folds. Data from this trial will support a pma application with the FDA. About Aquamid(R) Aquamid(R) is a soft volume ...ngoing in the United States. Data from these trials will be used to support pma applications for these products. Contura's products are developed, manufact...

Thoratec Announces FDA Approval of HeartMate II(R) for Bridge-To-Transplantation

...restore failing hearts, said today that it has received FDA approval of its pma (PreMarket Approval) application, allowing the use of its HeartMate II LVAS...atients enrolled in the trial. Highlights of the data included in the final pma submission included: -- The median duration of support was 132 days, a...
PMA in Medical Dictionary

Neutrophil

...utrophils leads to rapid release of HNP. ... Recirculation-induced neutrophil priming or exhaustion was tested by boosting ... The neutrophil pma response after recirculation was not altered compared to ... Abstract and Introduction: A high initial white blood cell count commonly occurs ...
PMA in Biological News

Almond pest management team to receive major award at ESA meeting

...lmond industry of California," wrote award nominator Peter Goodell, interim director of the UC IPM Program and a longtime UC IPM advisor. For example, pma research showed that almond growers need not spray for peach twig borer, navel orangeworm and San Jose scale every year. The Pesticide Use Report, ...

Stanford researchers publish review of US medical device regulation

...devices are subject to the most stringent controls and require pre-market approval (PMA) to ensure safety and effectiveness of the devices. The pma program and 510(K) pre-market notification program resemble the regulatory pathways often referred to by industry. The FDA quality systems regu...
PMA in Biological Technology

Thoratec Announces Filing of PMA Seeking Destination Therapy Approval for HeartMate II(R)

PLEASANTON, Calif., April 20 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR ), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today that it has filed a PMA (Pre-Market Approval) supplement with the FDA seeki...

Thoratec Announces HeartMate II(R) PMA Will be Reviewed by FDA Advisory Panel

PLEASANTON, Calif., Aug. 15 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR ), a world leader in products to treat cardiovascular disease, said today that its PMA (PreMarket Application) seeking approval of its HeartMate II for bridge-to-transplantation will undergo review by an ...

Angiotech Pharmaceuticals, Inc. announces financial results for the first quarter ended March 31, 2009

... is designed to be the first 38 millimeter drug-eluting stent available in the United States and will further expand this leading DES portfolio. These pma submissions include clinical data from the global, multi-center TAXUS ATLAS Small Vessel ("SV") and Long Lesion ("LL") studies, designed to compare th...

ATS Medical Provides Update on US Commercialization of Its ATS 3f Aortic Bioprosthesis

... valve holder accessory device. (Logo: http://www.newscom.com/cgi-bin/prnh/20040202/ATSILOGO ) While the ATS 3f Aortic Bioprosthesis pma was approved on October 30, 2008, as previously indicated, a full commercial launch would commence in the first quarter of 2009 once these milestones ...

CEO's Letter to Shareholders of Imaging Diagnostic Systems, Inc.

...n dollars to aid in the clinical collection of the pma data and the submission of the PMA application. ...red to support the intended use hypothesis for the pma application. Once the data required has been obtai...d by our bio-statisticians and formalized into the pma application for submission to the Food and Drug Ad...

ATS Medical Announces Record Quarterly Revenue and Gross Profit

...nounced previously, the Food and Drug Administration (FDA) has asked ATS to provide additional information and clarification in support of its pma for the ATS 3f Aortic Bioprosthesis. The Company submitted answers to the FDA in March 2008. Management continues to expect that the ATS 3f A...

Imaging Diagnostic Systems Accepts Resignations of Outside Directors

... Company Increases Focus on pma Study FORT LAUDERDALE, Fla., April 23 /PRNewswir...to achieve its financial goals and to complete the pma filing process." "As one of the original founder...essary to continue its operations and complete the pma process. I am strongly committed to turning the or...

Thoratec Reports 10 Percent Increase in Fiscal 2007 Revenues; Fourth Quarter Revenues Largest in Company History

...ter was the unanimous recommendation by the FDA Circulatory System Devices Advisory Panel on November 30 that the agency approve, with conditions, our pma (PreMarket Approval) allowing the use of our HeartMate II for Bridge to Transplant," Burbach noted. "It was the panel's view that the trial data dem...

Ferring Pharmaceuticals Announces EUFLEXXA(TM) as Title Sponsor of the National Senior Games Hockey Championships and the GeezerJock of the Year Award

...t derived from an avian source (chicken or rooster combs), the risk of reactions related to avian proteins is eliminated.(2-7) EUFLEXXA(TM) received pma approval from the U.S. Food and Drug Administration (FDA) on December 3, 2004, and became available to the public on November 8, 2005. For more inform...

Imaging Diagnostic Systems CEO Announces Retirement

...ee with Co-Chairman Patrick Gorman and me to further ensure a smooth transition," added Mr. Bendis. "We are optimistic about the future, with our US pma trials well underway and global commercialization gaining momentum. We are still a development- stage company but one with a large and growing clinica...
PMA in Biological Products
PMA in Biological Dictionary

Isozymes

...Expression of PKC isozymes in human basophils. To clarify which PKC isozymes were present in ... Downregulation of PKC isozymes with overnight pma treatment. ... Twelve different isozymes have now been described (29). Individual isozymes have been implicated in many cellular responses impo...
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