PMA P810031S079
- Device
- Healon PRO OVD, Healon5 PRO OVD, Healon GV PRO OVD
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P810031
- Supplement
- S079
- Product code
- LZP
- Decision date
- 2025-03-11
- Classification
- Ophthalmic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- modifications to the load capacity of one sterilization line and addition of another sterilization line
Current openFDA PMA Record#
- Device
- Healon PRO OVD, Healon5 PRO OVD, Healon GV PRO OVD
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P810031
- Supplement
- S079
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2025-03-11
- Decision code
- OK30
- Date received
- 2025-02-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- modifications to the load capacity of one sterilization line and addition of another sterilization line