Sensar Soft Acrylic UV-Light Absorbing Posterior Chamber Intraocular Lens
FDA premarket approval P980040/S098 · decided 2019-10-01
Approval details
- PMA number
- P980040
- Supplement
- S098
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Sensar Soft Acrylic UV-Light Absorbing Posterior Chamber Intraocular Lens
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2018-12-21
- Decision date
- 2019-10-01
- Days to decision
- 284 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for an additional packaging configuration for TECNIS®, TECNIS® OptiBlue, TECNIS® Multifocal, TECNIS® Toric, TECNIS® Symfony and TECNIS® Symfony Toric one-piece IOLs into the new Simplicity Delivery System.
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