Healon EndoCoat PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD); Healon Duet PRO II Dual Pack Sodium Hya
Johnson & Johnson Surgical Vision, Inc. · AID, SURGICAL, VISCOELASTIC · Ophthalmic
Open FDA's page for this record- PMA number
- P810031
- Supplement number
- S083
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Street 1
- 31 Technology Dr., Suite 200
- City
- Irvine
- State
- CA
- Zip
- 92618
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Trade name
- Healon EndoCoat PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD); Healon Duet PRO II Dual Pack Sodium Hya
- Product code
- LZP
- Advisory committee
- OP
- Advisory committee description
- Ophthalmic
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Expedited review flag
- N
- Date received
- 2026-07-27
- Decision date
- 2026-10-30
- Decision code
- APPR
- Ao statement
approval for a new cannula design for use with the Healon EndoCoat PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD) in both the individual pack and the Healon Duet PRO II Dual Pack
- Harmonized identifiers (openFDA)
- Device name
- Aid, Surgical, Viscoelastic
- Medical specialty description
- Ophthalmic
- Regulation number
- 886.4275
- Device class
- 3
- Registration number
- 1037089, 1064514, 2529709, 3002037047, 3039186269, 3005941719, 3000164186, 3004750704, 3003477135, 3015456951, 3007093114, 1038833, 3012236936, 2183744, 1610287, 1424263, 1211998, 3011965331, 1119279, 3009337401, 1313525, 9710098, 2083373, 2184002
- FEI number
- 1037089, 3002037047, 3039186269, 3000164186, 3004750704, 3003477135, 3003015552, 3002807111, 1000121259, 3015456951, 3007093114, 1000115753, 1038833, 3012236936, 3004161528, 2183744, 1610287, 1211998, 3011965331, 1119279, 3009337401, 3002957101, 2083373, 1317628