MODELS PCUB-32D0 AND PCUB-53D0
FDA premarket approval P830033/S023 · decided 1991-05-28
Approval details
- PMA number
- P830033
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODELS PCUB-32D0 AND PCUB-53D0
- Generic name
- intraocular lens
- Applicant
- Advanced Vision Science
- Date received
- 1990-10-10
- Decision date
- 1991-05-28
- Days to decision
- 230 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Goleta, CA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOINSULATED SILICONE PUNCTUM PLUG (K001234) | Advanced Vision Science | 2000-07-11 |
| SURGIDEV SILICONE PUNCTUM PLUG (K980844) | Advanced Vision Science | 1998-05-11 |