PMA P080010S020
- Device
- TECNIS Multifocal Foldable Posterior Chamber IOL
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P080010
- Supplement
- S020
- Product code
- MFK
- Decision date
- 2021-01-08
- Generic name
- Lens, multifocal intraocular
- Approval order statement
- Alternate ethylene oxide sterilization cycle parameters.
Current openFDA PMA Record#
- Device
- TECNIS Multifocal Foldable Posterior Chamber IOL
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P080010
- Supplement
- S020
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2021-01-08
- Decision code
- OK30
- Date received
- 2020-12-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate ethylene oxide sterilization cycle parameters.