SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVOCES (OVD), HEALON GV, HEALON5 PRODUCTS
FDA premarket approval P810031/S038 · decided 2010-11-22
Approval details
- PMA number
- P810031
- Supplement
- S038
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVOCES (OVD), HEALON GV, HEALON5 PRODUCTS
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2010-09-03
- Decision date
- 2010-11-22
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A LABELING CHANGE TO UPDATE THE LABELING THAT WAS APPROVED UNDER PMA SUPPLEMENT P810031/S017 TO REFLECT THE ABBOTT BRANDING GUIDELINES.
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