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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 NumberS002
Date Received02/09/2009
Decision Date03/11/2009
Withdrawal Date07/01/2020
Product Code OGO 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF A NEW REFRIGERATOR AT THE ALISO VIEJO FACILITY.
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