TECNIS ACRYLIC IOLS
FDA premarket approval P990080/S021 · decided 2007-04-26
Approval details
- PMA number
- P990080
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS ACRYLIC IOLS
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2007-03-27
- Decision date
- 2007-04-26
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- REDUCE OPERATOR HANDLING OF LENSES BY ELIMINATING THE 100% VISUAL INSPECTION PROCESSING STEP CONDUCTED AT POST-TUMBLING FOR ALL OF THE SOFT ACRYLIC IOLS.
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