TECNIS ACRYLIC IOL
FDA premarket approval P990080/S031 · decided 2008-09-30
Approval details
- PMA number
- P990080
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Trade name
- TECNIS ACRYLIC IOL
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2008-08-29
- Decision date
- 2008-09-30
- Days to decision
- 32 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGE IN THE SHEET CASTING PROCESS FOR MANUFACTURING THE DEVICE.
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| 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 |