SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES
FDA premarket approval P880081/S024 · decided 1999-07-02
Approval details
- PMA number
- P880081
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 1999-01-07
- Decision date
- 1999-07-02
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for modifications to the labeling for SLM-2/UV intraocular lenses (IOLs) to incorporate recent findings regarding the comparative incidence of posterior capsule opacification and Nd:YAG capsulotomy with silicone IOLs approved under this PMA versus polymethylmethacrylate (PMMA) IOLs.
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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 |