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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.
 
DeviceSTAAR SURGICAL AQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICE
Generic NameIntraocular pressure lowering implant
ApplicantStarr Surgical Co.
1911 Walker Ave.
Monrovia, CA 91016
PMA NumberP000026
Supplement NumberS001
Date Received07/23/2008
Decision Date09/10/2008
Withdrawal Date07/01/2020
Product Code OGO 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDING IN HOUSE LIMULUS AMEBOCYTE LYSATE TESTING.
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