TECNIS MULTIFOCAL LENS MODEL ZMA00
FDA premarket approval P080010/S007 · decided 2012-02-29
Approval details
- PMA number
- P080010
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS MULTIFOCAL LENS MODEL ZMA00
- Generic name
- Lens, multifocal intraocular
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2012-01-30
- Decision date
- 2012-02-29
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- IMPLEMENT A SOFTWARE AND HARDWARE UPGRADE TO THE EQUIPMENT USED TO MEASURE OPTICAL PROPERTIES OF INTRA- OCULAR LENSES.
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