PMA P980040S111
- Device
- TECNIS Toric 1-Piece Intraocular Lenses (IOL)
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Product code
- MJP
- Decision date
- 2020-06-11
- Generic name
- LENS, INTRAOCULAR, TORIC OPTICS
- Approval order statement
- Approval for modified labeling to reflect the findings of the post-approval study for the Models ZCT300 and ZCT400.
Current openFDA PMA Record#
- Device
- TECNIS Toric 1-Piece Intraocular Lenses (IOL)
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S111
- Product code
- MJP
- Generic name
- LENS, INTRAOCULAR, TORIC OPTICS
- Decision date
- 2020-06-11
- Decision code
- APPR
- Date received
- 2020-01-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for modified labeling to reflect the findings of the post-approval study for the Models ZCT300 and ZCT400.