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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSTAAR SURGICAL COMPANY AQUAFLOW(TM) COLLAGEN GLAUCOMA DRAINAGE DEVICE, MODEL CGDD-20
Generic NameIntraocular pressure lowering implant
ApplicantSTARR SURGICAL CO.
1911 WALKER AVE.
MONROVIA, CA 91016
PMA NumberP000026
Date Received07/07/2000
Decision Date07/12/2001
Withdrawal Date 07/01/2020
Product Code OGO 
Docket Number 01M-0307
Notice Date 07/23/2001
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MODEL CGDD-20 AQUAFLOW(TM) COLLAGEN DRAINAGE DEVICE. THE DEVICE IS INDICATED FOR THE MAINTENANCE OF A SUB-SCLERAL SPACE FOLLOWING NON-PENETRATING DEEP SCLERECTOMY USED TO FACILITATE AQUEOUS OUTFLOW FOR THE REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA WHERE INTRAOCULAR PRESSURE REMAINS UNCONTROLLED WHILE ON MAXIMALLY TOLERATED MEDICAL THERAPY.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 
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