Raindrop Near Vision Inlay
FDA premarket approval P150034/S004 · decided 2017-10-25
Approval details
- PMA number
- P150034
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Raindrop Near Vision Inlay
- Generic name
- Implant, corneal, refractive
- Applicant
- Rvo 2.0, Inc. (D.B.A. Optics Medical)
- Date received
- 2017-09-29
- Decision date
- 2017-10-25
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LQE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- Removal of a redundant chemical evaluation for two incoming materials.
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