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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.
 
DeviceRaindrop Near Vision Inlay
Generic NameImplant, corneal, refractive
ApplicantRVO 2.0, Inc. (d.b.a. Optics Medical)
65 Enterprise Suite 455
Aliso Viejo, CA 92656
PMA NumberP150034
Supplement NumberS006
Date Received12/18/2017
Decision Date01/12/2018
Product Code LQE 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Alternative shortened purification process for the Raindrop® Near Vision Inlay.
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