HEALON(R) SODIUM HYALURONATE
FDA premarket approval P810031/S022 · decided 1999-12-21
Approval details
- PMA number
- P810031
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HEALON(R) SODIUM HYALURONATE
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 1999-09-20
- Decision date
- 1999-12-21
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for a modification to the final product release testing requirements for the family of Healon(R) Sodium Hyaluronate viscoelastic products.
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