TECNIS ONE-PIECE SOFT ACRYLIC INTRAOCULAR (IOL) MODEL ZCB00 & TECNIS MULTIFOCAL ONE-PIECE IOL MODEL ZMB00
FDA premarket approval P980040/S034 · decided 2010-07-08
Approval details
- PMA number
- P980040
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS ONE-PIECE SOFT ACRYLIC INTRAOCULAR (IOL) MODEL ZCB00 & TECNIS MULTIFOCAL ONE-PIECE IOL MODEL ZMB00
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2010-06-10
- Decision date
- 2010-07-08
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- ADDITION OF A COSMETIC INSPECTION STEP TO THE MANUFACTURING PROCESS OF ONE-PIECE INTRAOCULAR LENSES.
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