Raindrop Near Vision Inlay
FDA premarket approval P150034/S008 · decided 2019-10-09
Approval details
- PMA number
- P150034
- Supplement
- S008
- 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
- 2019-08-19
- Decision date
- 2019-10-09
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- LQE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- Approval to temporarily suspend the New Enrollment PAS due to not distributing or marketing of the device.
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