TECNIS Symfony Toric Extended Range of Vision Intraocular Lens
FDA premarket approval P980040/S099 · decided 2019-06-26
Approval details
- PMA number
- P980040
- Supplement
- S099
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TECNIS Symfony Toric Extended Range of Vision Intraocular Lens
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2018-12-28
- Decision date
- 2019-06-26
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for the extension of the cylinder power range of the TECNIS Symfony Toric IOL line to include the cylinder powers 4.50D, 5.25D, and 6.00D.
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