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Article: STAAR Surgical PMA granted expedited review status by FDA.
- Article from:
- Medical Devices & Surgical Technology Week
- Article date:
- August 3, 2003
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2003 AUG 3 - (NewsRx.com & NewsRx.net) -- STAAR Surgical Co. (STAA), a developer, manufacturer, and marketer of minimally invasive ophthalmic products, announced that the premarket approval application (PMA) for its implantable contact lens (ICL) has been accepted for substantive review by the U.S. Food and Drug Administration (FDA) and has been granted an expedited review status.
The official filing date for the ICL PMA was May 8, 2003.
In notifying the company of the expedited review, the FDA said, "We believe that the Collamer Implantable Contact Lens (ICL) for Myopia may provide a clinically meaningful advantage over existing technology in terms of ...