Healon, Healo GV, Healon 5, Healon Ulrimate Dual Pack, Healon Duet Dual Pack products
FDA premarket approval P810031/S062 · decided 2017-07-20
Approval details
- PMA number
- P810031
- Supplement
- S062
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Healon, Healo GV, Healon 5, Healon Ulrimate Dual Pack, Healon Duet Dual Pack products
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2017-06-26
- Decision date
- 2017-07-20
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Change in the composition of the coating used inside the dissolution chambers.
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