PMA P110007S016
- Device
- Healon EndoCoat® Ophthalmic Viscosurgical Device (OVD) (3% Sodium Hyaluronate)
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P110007
- Supplement
- S016
- Product code
- LZP
- Decision date
- 2025-01-15
- Classification
- Ophthalmic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- a new manufacturing location for the same supplier of the glass syringe barrel
Current openFDA PMA Record#
- Device
- Healon EndoCoat® Ophthalmic Viscosurgical Device (OVD) (3% Sodium Hyaluronate)
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P110007
- Supplement
- S016
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2025-01-15
- Decision code
- OK30
- Date received
- 2024-12-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new manufacturing location for the same supplier of the glass syringe barrel