Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon, Healon GV, Healon5, Healon Ultimate Dual Pack, Healon
FDA premarket approval P810031/S064 · decided 2018-02-27
Approval details
- PMA number
- P810031
- Supplement
- S064
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon, Healon GV, Healon5, Healon Ultimate Dual Pack, Healon
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2018-02-02
- Decision date
- 2018-02-27
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Tightening of the endotoxin specification from 0.5 EU/ml to 0.2 EU/ml, an alternate Limulus Amebocyte Lysate (LAL) testing method, and a change to the sampling method for LAL testing for the Healon®, Healon5®, Healon GV®, Healon® Ultimate Dual Pack and Healon Duet® Dual Pack Ophthalmic Viscoelastic Devices (OVDs).
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