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. |
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Device | Raindrop Near Vision Inlay |
Generic Name | Implant, corneal, refractive |
Applicant | RVO 2.0, Inc. (d.b.a. Optics Medical) 65 Enterprise Suite 455 Aliso Viejo, CA 92656 |
PMA Number | P150034 |
Supplement Number | S006 |
Date Received | 12/18/2017 |
Decision Date | 01/12/2018 |
Product Code |
LQE |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Alternative shortened purification process for the Raindrop® Near Vision Inlay. |
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