NCRYSOF (R) UV ABSORBING INTRAOCULAR LENSES
FDA premarket approval P930014/S002 · decided 1996-03-26
Approval details
- PMA number
- P930014
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NCRYSOF (R) UV ABSORBING INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 1995-09-27
- Decision date
- 1996-03-26
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- ALTERNATE STERILIZATION PROCESS INCLUDING AERATION AND TH4E ESTABLISHMENT OF THE BIOLOGICAL INDICATOR INCUBATION TIME AT YOUR HUNTINGTON, WEST VIRGINIA SITE
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510(k) clearances by this applicant
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| UNITY VCS (8065000296); UNITY CS (8065000297) (K233876) | Alcon Laboratories, Inc. | 2024-06-21 |
| Centurion™ Vision System (Active Sentry™) (8065753057) (K233902) | Alcon Laboratories, Inc. | 2024-01-10 |
| Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal (K233856) | Alcon Laboratories, Inc. | 2023-12-29 |