TECNIS 1-Piece IOL with TECNIS Simplicity Delivery System, TECNIS OptiBlue 1-Piece IOL with TECNIS Simplicity Delivery S
FDA premarket approval P980040/S118 · decided 2020-11-04
Approval details
- PMA number
- P980040
- Supplement
- S118
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS 1-Piece IOL with TECNIS Simplicity Delivery System, TECNIS OptiBlue 1-Piece IOL with TECNIS Simplicity Delivery S
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2020-06-22
- Decision date
- 2020-11-04
- Days to decision
- 135 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for the alternate manufacturing and sterilization site is located at AMO Groningen B.V., 5 Van Swietenlaan, Groningen, The Netherlands 9728NX.
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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 |