TECNIS FOLDABLE ACRYLIC INTRAOCULAR LENS MODEL ZA9003
FDA premarket approval P990080/S006 · decided 2005-04-13
Approval details
- PMA number
- P990080
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TECNIS FOLDABLE ACRYLIC INTRAOCULAR LENS MODEL ZA9003
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2005-03-14
- Decision date
- 2005-04-13
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE TECNIS FOLDABLE ACRYLIC INTRAOCULAR LENS MODEL ZA9003 WITH CLAIMS REGARDING REDUCTION IN POSTOPERATIVE SPHERICAL ABERRATIONS COMPARED TO LENSES WITH SPHERICAL OPTICS AND IMPROVED NIGHT DRIVING SIMULATOR PERFORMANCE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ELITA™ Femtosecond Laser System, ELITA™ Patient Interface (K223566) | Johnson & Johnson Surgical Vision, Inc. | 2023-04-14 |
| VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control (K203060) | Johnson & Johnson Surgical Vision, Inc. | 2021-03-12 |
| UNFOLDER Vitan Inserter (K191949) | Johnson & Johnson Surgical Vision, Inc. | 2019-09-13 |
| COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal (K191933) | Johnson & Johnson Surgical Vision, Inc. | 2019-08-16 |