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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameGRIESHABER SCLERAL BUCKLING BALLOON CATHETER
Classification Namecatheter, balloon for retinal reattachment
Generic Namescleral buckling balloon catheter
ApplicantLABTICIAN OPHTHALMICS, INC.
PMA NumberP930024
Date Received03/16/1992
Decision Date06/02/1994
Withdrawal Date 01/14/2008
Product Code
LOG
Docket Number 94M-0229
Notice Date 07/22/1994
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
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