TECNIS 3PC MULTIFOCAL
FDA premarket approval P080010/S012 · decided 2016-01-12
Approval details
- PMA number
- P080010
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS 3PC MULTIFOCAL
- Generic name
- Lens, multifocal intraocular
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2015-12-18
- Decision date
- 2016-01-12
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- TO ADD 2 NEW CONTRACTORS TO PURIFY THE MONOMERS AND CROSS-LINKERS TO PRODUCE THE SILICONE MATERIAL USED IN THE ABOVE INTRAOCULAR LENSES.
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