FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implant, Corneal, Refractive
PMA: P150034
·
Supplement: S002
·
Decision Jan 24, 2018
Classifications
1
FEI Numbers
3
Registration Numbers
3
Basic Information
- Device Name
- Implant, Corneal, Refractive
- Trade Name
- ReVision Optics Raindrop Near Vision Inlay
- PMA Number
- P150034
- Supplement Number
- S002
- Device Class
- FDA Class 3
- Product Code
- LQE
- Generic Name
- Implant, corneal, refractive
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 24, 2018
- Date Received
- July 29, 2016
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol - OSB
- Expedited Review
- N
Advisory Committee Statement
Approval of the protocol for the post-approval study (PAS) protocol.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LQE | Implant, Corneal, Refractive | FDA class 3 | Unknown |