SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES(OVD),HEALON,HEALONGV,AND HEALON5 PRODUCTS
FDA premarket approval P810031/S048 · decided 2013-06-27
Approval details
- PMA number
- P810031
- Supplement
- S048
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES(OVD),HEALON,HEALONGV,AND HEALON5 PRODUCTS
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2013-05-28
- Decision date
- 2013-06-27
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CONVERSION OF AN EXISTING CLEAN ROOM SPACE INTO AN ADDITIONAL FORMULATION ROOM FOR THE USE IN THE PRODUCTION OF THE HEALON ENDOCOAT OVD.
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