SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5
FDA premarket approval P810031/S052 · decided 2015-04-02
Approval details
- PMA number
- P810031
- Supplement
- S052
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2015-02-18
- Decision date
- 2015-04-02
- Days to decision
- 43 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- MODIFY THE QUALITY CONTROL TEST METHODS AND/OR ACCEPTANCE CRITERIA ASSOCIATED WITH THE ABBOTT MEDICAL OPTICS (AMO) SODIUM HAYALURONATE (NAHY) SPECIFICATIONS.
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