Raindrop Near Vision Inlay
FDA premarket approval P150034/S003 · decided 2017-04-05
Approval details
- PMA number
- P150034
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Raindrop Near Vision Inlay
- Generic name
- Implant, corneal, refractive
- Applicant
- Rvo 2.0, Inc. (D.B.A. Optics Medical)
- Date received
- 2017-02-03
- Decision date
- 2017-04-05
- Days to decision
- 61 days
- Decision code
- APPR
- Product code
- LQE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- Approval for revisions to the Postoperative Care Following Inlay Implantation section of Instructions for Use (IFU) and Surgical Planning and Procedures of the Professional Use Information Brochure for the Raindrop Near Vision Inlay.
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