Healon EndoCoat Ophtalmic Viscosurgical Devices (OVD) (3% Sodium Hyaluronate)
FDA premarket approval P110007/S012 · decided 2020-05-11
Approval details
- PMA number
- P110007
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Healon EndoCoat Ophtalmic Viscosurgical Devices (OVD) (3% Sodium Hyaluronate)
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2020-04-29
- Decision date
- 2020-05-11
- Days to decision
- 12 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- 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).
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