TECNIS TORIC 1-PIECE IOL, MODEL ZCT375
FDA premarket approval P980040/S057 · decided 2015-04-17
Approval details
- PMA number
- P980040
- Supplement
- S057
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TECNIS TORIC 1-PIECE IOL, MODEL ZCT375
- Generic name
- LENS, INTRAOCULAR, TORIC OPTICS
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2015-01-29
- Decision date
- 2015-04-17
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- MJP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE TECNIS TORIC 1-PIECE IOL, MODEL ZCT375.
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