HEALON, HEALON GV AND HEALON5 SODIUM HYLAURONATE OPHTHALMIC VISCOELASTIC DEVICES
FDA premarket approval P810031/S031 · decided 2007-08-16
Approval details
- PMA number
- P810031
- Supplement
- S031
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HEALON, HEALON GV AND HEALON5 SODIUM HYLAURONATE OPHTHALMIC VISCOELASTIC DEVICES
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2006-09-29
- Decision date
- 2007-08-16
- Days to decision
- 321 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE TRANSFER AND EXPANSION OF THE QUALITY CONTROL MICROBIOLOGY LABORATORY USED FOR THE HEALON, HEALON GV AND HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES. THE TRANSFER INCLUDES TEST METHODS, PERSONNEL, AND EQUIPMENT FROM BUILDING 16 TO BUILDING 23 LOCATED IN UPPSALA, SWEDEN.
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