Staar Surgical -- know anything about it? Message Board

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Biotech / Medical : Staar Surgical -- know anything about it?

STAA 25.87

-2.5%

Oct 31 9:30 AM EDT

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To: Richard N Lambert who wrote (104)	9/23/1997 8:42:00 PM
From: Richard N Lambert	of 133

For anyone interested. I received the following response from Staar. September 23, 1997 Dear Mr. Lambert: Your e-mail inquiry dated 9/21/97 was forwarded to me for response. The ICL trials are underway and all Phase I myopic and hyperopic patients have been enrolled. We expect to be able to make a public annoucement regarding the hyperopic patient data soon as those patients reach the same postoperative follow-up the myopic patients were at when we made our recent announcement. The Glaucoma Wick is under review at FDA and I cannot yet comment on that project. STAAR intends to follow an IDE protocol developed collaboratively with the FDA that will lead to either a 510(k) substantial equivalence decision or a Pre-Market Approval (PMA) sometime down the road. In either case, the IDE study will be the component that requires the most time and the requirement for either a 510(k) or PMA filing should not impede market introduction severely. The STAARVISC material is under review at FDA. I cannot predict when FDA might make an approval decision, however, at this point, no major deficiencies requiring correction have been identified. I hope this addresses your immediate concerns. Sincerely, Steven L. Ziemba Vice-President, Regulatory Affairs -- Steven L. Ziemba, M.S.

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