TECNIS Toric 1-Piece Intraocular Lenses (IOL)
FDA premarket approval P980040/S111 · decided 2020-06-11
Approval details
- PMA number
- P980040
- Supplement
- S111
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- TECNIS Toric 1-Piece Intraocular Lenses (IOL)
- Generic name
- LENS, INTRAOCULAR, TORIC OPTICS
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2020-01-29
- Decision date
- 2020-06-11
- Days to decision
- 134 days
- Decision code
- APPR
- Product code
- MJP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for modified labeling to reflect the findings of the post-approval study for the Models ZCT300 and ZCT400.
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|---|---|---|
| ELITA™ Femtosecond Laser System, ELITA™ Patient Interface (K223566) | Johnson & Johnson Surgical Vision, Inc. | 2023-04-14 |
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| 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 |