TECNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL) WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM
FDA premarket approval P980040/S056 · decided 2015-03-17
Approval details
- PMA number
- P980040
- Supplement
- S056
- Supplement type
- Normal 180 Day Track
- Trade name
- TECNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL) WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM
- Generic name
- LENS, INTRAOCULAR, TORIC OPTICS
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2014-12-24
- Decision date
- 2015-03-17
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- MJP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A CHANGE TO THE PACKAGING OF THE MODEL SERIES ZCT INTRAOCULAR LENSES (IOL) FROM A WHEELCASE CONFIGURATION TO A PRELOADED PACKAGING CONFIGURATION/DELIVERY SYSTEM. THE PRELOADED LENS MODELS WILL BE BRANDED UNDER THE NAME ¿TECNIS® TORIC 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM, MODELS PCT150, PCT225, PCT300 AND PCT400.¿
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