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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.
 
DeviceIMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X
Generic NameTelescope, implantable, miniature
ApplicantSamsara Vision Inc.
27 US Highway 202
Suite 8/9
Far Hills, NJ 07931
PMA NumberP050034
Supplement NumberS009
Date Received05/15/2013
Decision Date11/05/2013
Product Code NCJ 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE APPROVED PROFESSIONAL USE INFORMATION AND PATIENT INFORMATION BOOKLET TO ADD INFORMATION OBTAINED FROM POST-APPROVAL STUDY IMT-002-LTME.
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