TECNIS Symfony PLUS Extended Range of Vision Intraocular Lens (IOL), Model ZHR00, TECNIS Symfony PLUS Extended Range of
FDA premarket approval P980040/S109 · decided 2020-05-01
Approval details
- PMA number
- P980040
- Supplement
- S109
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TECNIS Symfony PLUS Extended Range of Vision Intraocular Lens (IOL), Model ZHR00, TECNIS Symfony PLUS Extended Range of
- Generic name
- Extended depth of focus intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2019-11-06
- Decision date
- 2020-05-01
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- POE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for the modification of the optics to elongate the depth of focus further than the optical parent lens, the TECNIS Symfony Extended Range of Vision IOL, Model ZXR00.
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