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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 NameVISIONCARE'S IMPLANTABLE MINIATURE TELESCOPE
Classification Nametelescope, implantable, miniature
ApplicantVISION CARE OPHTHALMIC TECHNOLOGIES, LTD.
PMA NumberP050034
Supplement NumberS001
Date Received08/30/2010
Decision Date10/07/2010
Product Code
NCJ[ Registered Establishments with NCJ ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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