SENSAR & TECNIS ONE-PIECE ACRYLIC POSTERIOR CHAMBER IOLS (MODELS AAB00 & ZCB00)
FDA premarket approval P980040/S015 · decided 2007-10-30
Approval details
- PMA number
- P980040
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SENSAR & TECNIS ONE-PIECE ACRYLIC POSTERIOR CHAMBER IOLS (MODELS AAB00 & ZCB00)
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2007-05-18
- Decision date
- 2007-10-30
- Days to decision
- 165 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR TWO NEW MODELS OF SENSAR SOFT ACRYLIC UV LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS) AND THE CLAIMS FOR REDUCED POSTOPERATIVE SPHERICAL ABERRATIONS AND IMPROVED NIGHT-DRIVING SIMULATOR PERFORMANCE. THE NEW MODELS ARE SENSAR ONE-PIECE ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL AAB00) AND TECNIS ONE-PIECE ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL ZCB00). THE TWO MODELS DIFFER FROM THE PARENT MODELS AS FOLLOWS: SINGLE PIECE DESIGN, THE ADDITION OF A SURFA
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