5ODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL
FDA premarket approval P880081/S018 · decided 1995-07-28
Approval details
- PMA number
- P880081
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 5ODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 1995-04-04
- Decision date
- 1995-07-28
- Days to decision
- 115 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR SINGLE-POUCH TYVEK PACKAGING OF LENSES PRODUCED IN IRVINE, CA & ANASCO, PR, STERILZATION OF LENSES USING PREVIOUSLY APPROVED 100% ETO STERILIZATION CYCLES & A 5 YEAR SHELF LIFE FOR SINGLE POUCH/100% ETO STERILIZED LENSES
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