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Biotech / Medical : SNRS- Sunrise Technologies

SNRS 0.000001000

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Jun 6 11:01 AM EST

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To: Kevin Podsiadlik who wrote (3465)	11/30/1999 6:25:00 PM
From: Joe	Read Replies (2) of 4140

Kevin, Dr. Marcian Macsai, one of the reviewers that trashed SNRS before the ODP said in her remarks that Sunrise would need 300 eyes at 24 months with 90% accountability and then added "or you tell us what is needed." directing her comment to Dr. Rosenthal, the Ophthalmic Devices Chief at FDA. So if SNRS does not have 300 eyes at 24 months and FDA is taking the PMA back to Panel, it sounds like the FDA will be telling the Panel what is acceptable criteria. BTW, Dr. Macsai's term has expired and she did not participate in the September meeting. I think this is indicative that she will not participate in the January Panel. Joe

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