FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Implant, Corneal, Refractive
PMA: P150034
·
Supplement: S004
·
Decision Oct 25, 2017
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
- S004
- Device Class
- FDA Class 3
- Product Code
- LQE
- Generic Name
- Implant, corneal, refractive
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- October 25, 2017
- Date Received
- September 29, 2017
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Removal of a redundant chemical evaluation for two incoming materials.
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 |