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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)
Generic NameTelescope, implantable, miniature
ApplicantSamsara Vision, Inc.
27 Us Hwy. 202, Suite 8/9
Far Hills, NJ 07931
PMA NumberP050034
Supplement NumberS016
Date Received09/23/2016
Decision Date12/20/2016
Product Code NCJ 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a design change to reposition the eyelet on each haptic (loop) of the carrier of the IMT to the distal end of the haptic.
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