Tue, 23 Dec 2014 16:13:00 GMT ~ Advanced Medical Isotope Corporation Files a "de novo" Submission for Y-90 RadioGel(TM) Device
[PR Newswire] - In February 2014, the FDA rejected the Company's request for marketing clearance for the same device under Section 510(k) of the Act. The FDA determined that the device was not substantially equivalent, concluding that the device is classified by statute as a Class III medical device, unless the device is reclassified. By filing the de novo submission, the Company is seeking reclassification of the product to Class II. The FDA has 120 days in which to make a decision, though the period will be extended for any time AMIC requires to respond to FDA requests for additional information. If the de novo submission is granted, the device may be immediately marketed in the United States, though the Company would have to secure funding and commercial arrangements before marketing could commence. If the de novo submission is declined, the Company will explore steps toward seeking approval for the device as a Class III medical device. Generally, the time period and cost of seeking approval as a Class III medical device is materially greater than the time period and cost of seeking approval as a Class II medical device.
Fri, 19 Dec 2014 22:49:00 GMT ~ Advanced Medical Isotope Corporation Awarded LSDF Grant As Commercialization Partner
[Accesswire] - Kennewick, WA / ACCESSWIRE / December 19, 2014 / Advanced Medical Isotope Corporation ("AMIC") ( OTCQB: ADMD ), a late stage development company engaged primarily in the development of brachytherapy ...
Fri, 19 Dec 2014 18:25:00 GMT ~ Advanced Medical Isotope Corporation Awarded LSDF Grant As Commercialization Partner
[PR Newswire] - KENNEWICK, Wash., Dec. 19, 2014 /PRNewswire/ -- Advanced Medical Isotope Corporation ("AMIC") (OTCQB: ADMD), a late stage development company engaged primarily in the development of brachytherapy ...
Link: http://www.otcmarkets.com/stock/ADMD/company-info Ticker: $ADMD OTC Market Place: OTC Pink Current CIK code: 0001449349 Company name: Advanced Medical Isotope Corp. Company website: http://www.isotopeworld.com Incorporated In: DE, USA
Business Description: Produces and distributes medical isotopes.
$ADMD share structure
## source: otcmarkets.com
Market Value: $129,504 a/o Jan 07, 2015 Shares Outstanding: 185,005,501 a/o Aug 14, 2014 Float: 18,749,307 a/o Sep 30, 2012 Authorized Shares: 200,000,000 a/o Sep 30, 2012 Par Value: 0.001
$ADMD extra dd links
Company name: Advanced Medical Isotope Corp. Company website: http://www.isotopeworld.com
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