Sodium Hyaluronate Ophtalmic Viscoelastic Devices (OVD), Healon Duet Dual Pack and Healon Duet PRO Dual Pack
FDA premarket approval P810031/S067 · decided 2020-05-11
Approval details
- PMA number
- P810031
- Supplement
- S067
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Sodium Hyaluronate Ophtalmic Viscoelastic Devices (OVD), Healon Duet Dual Pack and Healon Duet PRO Dual Pack
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2020-04-29
- Decision date
- 2020-05-11
- Days to decision
- 12 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Removal of an in-process raw material quality control test affecting the sodium hyaluronate (NaHy) raw material for the Healon EndoCoat® Ophthalmic ViscosurgicalDevice (OVD).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ELITA™ Femtosecond Laser System, ELITA™ Patient Interface (K223566) | Johnson & Johnson Surgical Vision, Inc. | 2023-04-14 |
| VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control (K203060) | Johnson & Johnson Surgical Vision, Inc. | 2021-03-12 |
| UNFOLDER Vitan Inserter (K191949) | Johnson & Johnson Surgical Vision, Inc. | 2019-09-13 |
| COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal (K191933) | Johnson & Johnson Surgical Vision, Inc. | 2019-08-16 |