HEALON 5 SODIUM HYALURONATE
FDA premarket approval P810031/S023 · decided 2000-11-22
Approval details
- PMA number
- P810031
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Trade name
- HEALON 5 SODIUM HYALURONATE
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2000-05-12
- Decision date
- 2000-11-22
- Days to decision
- 194 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR HEALON(R)5 SODIUM HYALURONATE VISCOELASTIC.
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