Raindrop® Near Vision Inlay

FDA Premarket Approval P150034 S009

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.

Pre-market Approval Supplement Details

Approval to place the study on hold for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p150034.

DeviceRaindrop® Near Vision Inlay
Generic NameImplant, Corneal, Refractive
ApplicantRVO 2.0, Inc. (d.b.a. Optics Medical)
Date Received2021-12-09
Decision Date2022-01-04
PMAP150034
SupplementS009
Product CodeLQE 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination Product No
Applicant Address RVO 2.0, Inc. (d.b.a. Optics Medical) 65 Enterprise Suite 455 aliso Viejo, CA 92656

Supplemental Filings

Supplement NumberDateSupplement Type
P150034Original Filing
S009 2021-12-09 Normal 180 Day Track No User Fee
S008 2019-08-19 Normal 180 Day Track No User Fee
S007 2017-12-21 Normal 180 Day Track No User Fee
S006 2017-12-18 30-day Notice
S005 2017-09-29 Normal 180 Day Track
S004 2017-09-29 30-day Notice
S003 2017-02-03 Special (immediate Track)
S002 2016-07-29 Normal 180 Day Track No User Fee
S001 2016-07-29 Normal 180 Day Track No User Fee

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