TECNIS Eyhance Toric II, Model ICU, TECNIS Eyhance Toric II with TECNIS Simplicity® Delivery System, TECNIS Synergy T
FDA premarket approval P980040/S148 · decided 2022-07-20
Approval details
- PMA number
- P980040
- Supplement
- S148
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS Eyhance Toric II, Model ICU, TECNIS Eyhance Toric II with TECNIS Simplicity® Delivery System, TECNIS Synergy T
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2022-06-24
- Decision date
- 2022-07-20
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Adoption of additional intraocular lens models and packaging configurations into the existing approved sterilization process, SPS100, using sterilization vessel #8 and hot cell #5, at AMO Puerto Rico site.
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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 |