- Device
- Sodium Hyaluronate OphthalmicViscoelastic Devices (OVD), Healon PRO, Healon GV PRO, Healon5 PRO and Healon Duet PRO Dual
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P810031
- Supplement
- S072
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2021-07-13
- Decision code
- OK30
- Date received
- 2021-06-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change from sterility testing to parametric release for product release of the Healon® PRO (packaged individually and in the Healon® Duet PRO Dual Pack), Healon5® PRO and Healon® GV PRO ophthalmic viscoelastic devices (OVDs), in their primary glass syringe packaging, following moist heat steam sterilization.