PMA P980040S085
- Device
- TECNIS Symfony 1-Piece IOL, TECNIS Multifocal 1-Piece IOL, and TECNIS Multifocal 1-Piece IOL
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S085
- Product code
- HQL
- Decision date
- 2017-12-12
- Classification
- Intraocular Lens
- Generic name
- intraocular lens
- Approval order statement
- Utilization of an additional manufacturing site.
Current openFDA PMA Record#
- Device
- TECNIS Symfony 1-Piece IOL, TECNIS Multifocal 1-Piece IOL, and TECNIS Multifocal 1-Piece IOL
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S085
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2017-12-12
- Decision code
- OK30
- Date received
- 2017-11-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Utilization of an additional manufacturing site.