TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P080010/S001 · decided 2009-06-12
Approval details
- PMA number
- P080010
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Trade name
- TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS
- Generic name
- Lens, multifocal intraocular
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2009-01-27
- Decision date
- 2009-06-12
- Days to decision
- 136 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR CHANGES TO THE LABELING FOR THE TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL), MODELS ZM900 AND ZMA00, REVISION THE DIRECTIONS FOR USE (DFU) AND THE PATIENT BROCHURE FOR THE LENS MODELS WITH UPDATED ONE-YEAR FOLLOW UP DATA FROM THE CLINICAL INVESTIGATION FOR THE LENSES.
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