TECNIS FOLDABLE ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENS (IOL), MODEL AR40XEM
FDA premarket approval P980040/S007 · decided 2007-01-04
Approval details
- PMA number
- P980040
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TECNIS FOLDABLE ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENS (IOL), MODEL AR40XEM
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2005-09-30
- Decision date
- 2007-01-04
- Days to decision
- 461 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO MARKET MODEL AR40XEM INTRAOCULAR LENS (IOL) UNDER THE TECNIS TRADE NAME AND FOR THE FOLLOWING LABELING CLAIMS: 1) IMPROVED MESOPIC CONTRAST SENSITIVITY; 2) IMPROVED MESOPIC LOW-CONTRAST ACUITY; AND 3) REDUCED SPHERICAL ABERRATION.
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