PMA P810031S068
- Device
- Ophthalmic Viscoelastic Devices, Healon Duet Dual Pack and Healon Duet PRO Dual Pack
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P810031
- Supplement
- S068
- Product code
- LZP
- Decision date
- 2020-12-02
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- Expansion of the Lifecore Biomedical quality control (QC) laboratory.
Current openFDA PMA Record#
- Device
- Ophthalmic Viscoelastic Devices, Healon Duet Dual Pack and Healon Duet PRO Dual Pack
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P810031
- Supplement
- S068
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2020-12-02
- Decision code
- OK30
- Date received
- 2020-10-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expansion of the Lifecore Biomedical quality control (QC) laboratory.