5ODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL
FDA premarket approval P880081/S020 · decided 1996-03-11
Approval details
- PMA number
- P880081
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- 5ODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 1995-11-13
- Decision date
- 1996-03-11
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO ADD STERILIZATION SERVICES OF TENNESSEE (SST) AS AN ALTERNATE 100% ETO STERILIZATION SITE FOR IOLS PRODUCED IN IRVINE, CA AND ANASCO, PR AND PACKAGED IN THE SINGLE-POUCH TYVEK PACKAGING CONFIGURATIN CURRENTLY APPROVED UNDER THESE PMAS FOR STERILIZATION AT STERILIZATION SERVICES OF GEORGIA(SSG)
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 |