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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 NumberS009
Date Received12/09/2021
Decision Date01/04/2022
Product Code LQE 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to place the study on hold for the post-approval study (PAS) protocol.
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