Pre-Market Approval Application


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Pre-Market Approval Application

An application to FDA for a licence to market a new device in the United States.
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VANCOUVER, June 1 /PRNewswire/ -- In recent news releases CTC (Nasdaq: CRTCF) disclosed that the Food and Drug Administration (FDA) had accepted its Pre-Market Approval application (PMA) in support of the ETG device as a treatment for common baldness in males, for filing.
VANCOUVER, May 31 /PRNewswire/ -- In recent news releases CTC (Nasdaq: CRTCF) disclosed that the Food and Drug Administration (FDA) had accepted its Pre-Market Approval application (PMA) in support of the ETG device as a treatment for common baldness in males, for filing.
The Company's pending Pre-Market Approval application for its Memory Gel(TM) breast implant products is currently under review by the U.
In November 1993, the company submitted to the Food and Drug Administration (FDA) a Pre-Market Approval Application (PMA) in support of the ETG device as a treatment for common baldness in males.
be preceded either by a pre-market notification clearance order under section 510(k) of the Food, Drug and Cosmetic Act, or an approved pre-market approval application.
NASDAQ: TLIO) announced that it has resubmitted its amended Pre-Market Approval application ("PMA") for the use of ARGIDENE(TM) Gel in the treatment of diabetic foot ulcers.
NYSE: MB) (MBI) today updated the progress of the Pre-Market Approval application (PMA) for Albunex(R), its pioneering cardiac ultrasound contrast agent, by announcing that it has received a letter from the U.
In related news, Anika also announced that, subsequent to such termination, it has filed a pre-market approval application (PMA) with the U.
In March 1993, Telios submitted a Pre-Market Approval application (PMA) to the U.
This round of financing will enable us to conduct the final phase of our acute MI pivotal trial, submit our Pre-Market Approval application to the FDA, and scale up manufacturing," commented Kevin T.
Aastrom hopes to file Pre-Market Approval applications later this year with the Food and Drug Administration (FDA) to gain approval to sell the kits.