FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Intraocular Lens
PMA: P980040
·
Supplement: S171
·
Decision Sep 10, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Intraocular Lens
- Trade Name
- SENSAR Soft Acrylic Posterior Chamber IOL, SENSAR 1-piece IOL, TECNIS 1-Piece IOL, TECNIS Multifocal 1-Piece IOL, TECNIS
- PMA Number
- P980040
- Supplement Number
- S171
- 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
- September 10, 2025
- Date Received
- December 23, 2024
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
approval for a new sterilization manufacturing site located at COSMED Group of Dominican Republic, Zona Franca Las Americas Km. 22 Autopista Las Americas, Santo Domingo Este Calle 15Esq. Calle 10, Santo Domingo, Santo Domingo, Dominican Republic
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 |