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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)
Classification Nametelescope, implantable, miniature
ApplicantVISION CARE OPHTHALMIC TECHNOLOGIES, LTD.
PMA NumberP050034
Supplement NumberS005
Date Received03/02/2011
Decision Date03/31/2011
Product Code
NCJ[ Registered Establishments with NCJ ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change the biological indicator used in the sterilization process and to add an option for a second full cycle sterilization (double sterilization) to the manufacturing process if required.
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