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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 NumberS005
Date Received09/29/2017
Decision Date03/27/2018
Product Code LQE 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to update the device labeling with the 36-month results for the Raindrop® Near Vision Inlay. In addition, the labeling includes minor changes (changing the temperature limit symbol maximum from 55°C to 25°C, removal of translations, updates to the Instructions for Use).
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