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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSTAAR SURGICAL AQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICE
Classification Nameintraocular pressure lowering implant
ApplicantSTARR SURGICAL CO.
PMA NumberP000026
Supplement NumberS002
Date Received02/12/2009
Decision Date03/11/2009
Product Code
OGO[ Registered Establishments with OGO ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a new refrigerator at the aliso viejo facility.
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