REVISION OPTICS RAINDROP NEAR VISION INLAY
FDA premarket approval P150034/S001 · decided 2016-12-27
Approval details
- PMA number
- P150034
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- REVISION OPTICS RAINDROP NEAR VISION INLAY
- Generic name
- Implant, corneal, refractive
- Applicant
- Rvo 2.0, Inc. (D.B.A. Optics Medical)
- Date received
- 2016-07-29
- Decision date
- 2016-12-27
- Days to decision
- 151 days
- Decision code
- APPR
- Product code
- LQE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- Approval of the protocol for the post-approval study (PAS) protocol.
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