FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implant, Corneal, Refractive
PMA: P150034
·
Supplement: S005
·
Decision Mar 27, 2018
Classifications
1
FEI Numbers
3
Registration Numbers
3
Basic Information
- Device Name
- Implant, Corneal, Refractive
- Trade Name
- Raindrop Near Vision Inlay
- PMA Number
- P150034
- Supplement Number
- S005
- 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
- March 27, 2018
- Date Received
- September 29, 2017
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval to update the device labeling with the 36-month results for the Raindrop® Near Vision Inlay. In addition, the labeling includes minor changes (changing the temperature limit symbol maximum from 55°C to 25°C, removal of translations, updates to the Instructions for Use).
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 |