Raindrop Near Vision Inlay
FDA premarket approval P150034/S007 · decided 2018-02-15
Approval details
- PMA number
- P150034
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Raindrop Near Vision Inlay
- Generic name
- Implant, corneal, refractive
- Applicant
- Rvo 2.0, Inc. (D.B.A. Optics Medical)
- Date received
- 2017-12-21
- Decision date
- 2018-02-15
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- LQE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- Approval for proposed reporting changes to the Post-Approval Study (PAS) protocol.
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