PMA P980040S056
- Device
- TECNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL) WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S056
- Product code
- MJP
- Decision date
- 2015-03-17
- Classification
- Lens, Intraocular, Toric Optics
- Generic name
- LENS, INTRAOCULAR, TORIC OPTICS
- Approval order 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.¿
Current openFDA PMA Record#
- Device
- TECNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL) WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S056
- Product code
- MJP
- Generic name
- LENS, INTRAOCULAR, TORIC OPTICS
- Decision date
- 2015-03-17
- Decision code
- APPR
- Date received
- 2014-12-24
- Supplement type
- Normal 180 Day Track
- Approval order 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.¿