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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICES
Generic NameIntraocular pressure lowering implant
ApplicantStarr Surgical Co.
1911 Walker Ave.
Monrovia, CA 91016
PMA NumberP000026
Supplement NumberS003
Date Received05/01/2010
Decision Date06/17/2010
Withdrawal Date07/01/2020
Product Code OGO 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MINOR LABELING CHANGE FOR THE DEVICE.
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