- Device
- Healon EndoCoat Ophtalmic Viscosurgical Devices (OVD) (3% Sodium Hyaluronate)
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P110007
- Supplement
- S012
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2020-05-11
- Decision code
- OK30
- Date received
- 2020-04-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of an in-process raw material quality control test affecting the sodium hyaluronate (NaHy) raw material for the Healon EndoCoat® Ophthalmic ViscosurgicalDevice (OVD).