PMA P980040S127
- Device
- SENSAR 3-Piece Monofocal IOLs with OptiEdge Design, SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS Multifocal 1-Piece IO
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S127
- Product code
- HQL
- Decision date
- 2021-01-08
- Generic name
- intraocular lens
- Approval order statement
- Alternate ethylene oxide sterilization cycle parameters.
Current openFDA PMA Record#
- Device
- SENSAR 3-Piece Monofocal IOLs with OptiEdge Design, SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS Multifocal 1-Piece IO
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S127
- Product code
- HQL
- Generic name
- intraocular lens
- 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.