FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Intraocular Lens
PMA: P090022
·
Supplement: S013
·
Decision Aug 16, 2012
Classifications
1
FEI Numbers
59
Registration Numbers
59
Basic Information
- Device Name
- Intraocular Lens
- Trade Name
- SOFTEC HD POSTERRIOR CHAMBER INTRAOCULAR LENS (PCIOL)
- PMA Number
- P090022
- Supplement Number
- S013
- Device Class
- FDA Class 3
- Product Code
- HQL
- Generic Name
- intraocular lens
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 16, 2012
- Date Received
- July 24, 2012
- Supplement Type
- Special (Immediate Track)
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A MODIFICATION TO THE DIRECTIONS FOR USE TO INCLUDE A WARNING THAT ENHANCES THE SAFETY IN THE USE OF THE DEVICE.
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 |
|---|---|---|---|
| HQL | Intraocular Lens | FDA class 3 | Ophthalmic |