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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSTAAR SURGICAL COMPANY AQUAFLOW(TM) COLLAGEN GLAUCOMA DRAINAGE DEVICE, MODEL CGDD-20
Classification Nameintraocular pressure lowering implant
ApplicantSTARR SURGICAL CO.
PMA NumberP000026
Date Received07/07/2000
Decision Date07/12/2001
Product Code
OGO[ Registered Establishments with OGO ]
Docket Number 01M-0307
Notice Date 07/23/2001
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Supplements: S001 S002 S003 
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