HEALON D SODIUM HYALURONATE SOLUTION
FDA premarket approval P880031/S016 · decided 2009-02-18
Approval details
- PMA number
- P880031
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HEALON D SODIUM HYALURONATE SOLUTION
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Abbott Medical Optics, Inc.
- Date received
- 2009-01-08
- Decision date
- 2009-02-18
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- APPROVAL TO CHANGE THE PH PRODUCT SPECIFICATION RANGE FOR HEALON D FROM 7.1 ¿ 7.5 TO 6.8 ¿ 7.6.
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| IFS LASER SYSTEM (K113151) | Abbott Medical Optics, Inc. | 2012-03-08 |