TECNIS Symfony Extended Range Of Vision Intraocular Lens
FDA premarket approval P980040/S161 · decided 2023-12-22
Approval details
- PMA number
- P980040
- Supplement
- S161
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- TECNIS Symfony Extended Range Of Vision Intraocular Lens
- Generic name
- Extended depth of focus intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2023-07-03
- Decision date
- 2023-12-22
- Days to decision
- 172 days
- Decision code
- APPR
- Product code
- POE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- approval of modifications to the final professional and patient labeling for the TECNIS Symfony Extended Range Of Vision Intraocular Lens (Models ZXR00 and ZXT 150-600) to include the results of your postmarket study.
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510(k) clearances by this applicant
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|---|---|---|
| ELITA™ Femtosecond Laser System, ELITA™ Patient Interface (K223566) | Johnson & Johnson Surgical Vision, Inc. | 2023-04-14 |
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| 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 |