HEALON,HEALON GV, & HEALON5 SODIUM HYALURONATE VISCOELASTIC
FDA premarket approval P810031/S033 · decided 2007-08-30
Approval details
- PMA number
- P810031
- Supplement
- S033
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HEALON,HEALON GV, & HEALON5 SODIUM HYALURONATE VISCOELASTIC
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2006-12-11
- Decision date
- 2007-08-30
- Days to decision
- 262 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A DIFFERENT RELEASE AGENT TO BE USED WITH THEIR EXISTING PETG MATERIAL IN THE OUTER BLISTER TRAY FOR THE SECONDARY PACKAGING OF ALL OF THE HEALON OPHTHALMIC VISCOELASTIC PRODUCTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES: HEALON, HEALON GV AND HEALON5 SODIUM HYALURONATE AND IS INTENDED TO BE INTRODUCED INTO THE EYE TO AID PERFORMANCE OF SURGERY, SUCH AS TO MAINTAIN ANTERIOR CHAMBER DEPTH, PRESERVE TISSUE INTEGRITY, PROTECT TISSUE FROM SURGICAL TRAUMA, OR FUNCT
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 |