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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 NumberS007
Date Received12/04/2012
Decision Date12/27/2012
Product Code NCJ 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
IMPLEMENTATION OF A HOLDING SYSTEM USING NITROGEN GAS IN LASER WELDING SYSTEM I (LWSI).
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