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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 NameIMPLANTABLE MINIATURE TELESCOPE (IMT) MODES WIDE ANGLE 2.2X & WIDE ANGLE 2.7X
Classification Nametelescope, implantable, miniature
ApplicantVISION CARE OPHTHALMIC TECHNOLOGIES, LTD.
PMA NumberP050034
Supplement NumberS006
Date Received12/27/2011
Decision Date02/23/2012
Product Code
NCJ[ Registered Establishments with NCJ ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the information regarding the safety of the device during mri exposure to the patient information booklet.
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