TECNIS 1- PIECE IOL WITH TECNIS ITEC, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC, AND TECNIS TORIC 1-PIECE IOL
FDA premarket approval P980040/S060 · decided 2015-04-17
Approval details
- PMA number
- P980040
- Supplement
- S060
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS 1- PIECE IOL WITH TECNIS ITEC, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC, AND TECNIS TORIC 1-PIECE IOL
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2015-03-23
- Decision date
- 2015-04-17
- Days to decision
- 25 days
- Decision code
- OK30
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- ALTERNATIVE MOLDING SUPPLIER FOR THE UPPER BODY COMPONENT OF THE TECNIS® PRELOADED DELIVERY SYSTEMS (MODELS PCB00, PMB00, PCT150, PCT225, PCT300, AND PCT400) AND AN ALTERNATIVE MOLD SUPPLIER FOR THE 1MTEC30 CARTRIDGE, LOWER BODY AND PROTECTOR CAP COMPONENTS.
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 |