TECNIS Toric 1-Piece Intraocular Lense (IOLs)
FDA premarket approval P980040/S115 · decided 2020-10-14
Approval details
- PMA number
- P980040
- Supplement
- S115
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- TECNIS Toric 1-Piece Intraocular Lense (IOLs)
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2020-04-17
- Decision date
- 2020-10-14
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for labeling modification to reflect the findings of the Post-Approval Study (PAS) for Models ZCT450, ZCT525, and ZCT600.
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| ELITA™ Femtosecond Laser System, ELITA™ Patient Interface (K223566) | Johnson & Johnson Surgical Vision, Inc. | 2023-04-14 |
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