TECNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TENCNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TECNIS TORIC 1-PIECE INTRAOCU
FDA premarket approval P980040/S058 · decided 2015-07-31
Approval details
- PMA number
- P980040
- Supplement
- S058
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TECNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TENCNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TECNIS TORIC 1-PIECE INTRAOCU
- Generic name
- LENS, INTRAOCULAR, TORIC OPTICS
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2015-02-02
- Decision date
- 2015-07-31
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- MJP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR TECNIS® TORIC 1-PIECE ACRYLIC IOLS, MODELS ZCT450, ZCT525 AND ZCT600, AND THE TECNIS® TORIC CALCULATOR.
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