TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) MODEL ZMA00
FDA premarket approval P080010/S005 · decided 2010-04-28
Approval details
- PMA number
- P080010
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) MODEL ZMA00
- Generic name
- Lens, multifocal intraocular
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2010-04-01
- Decision date
- 2010-04-28
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGE FROM MANUAL TO AUTOMATED ROTATION DURING THE HOLE-DRILLING STEP.
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