SINGLE-PIECE AND THREE PIECE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)
FDA premarket approval P830033/S027 · decided 1996-01-29
Approval details
- PMA number
- P830033
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SINGLE-PIECE AND THREE PIECE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)
- Generic name
- intraocular lens
- Applicant
- Advanced Vision Science
- Date received
- 1994-07-28
- Decision date
- 1996-01-29
- Days to decision
- 550 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Goleta, CA
- Statement
- APPROVAL TO CHANGE VENDORS OF THE POLYMETHYLMETHACRYLATE (PMMA) MATERIAL USED TO MANUFACTURE IOLS APROVED UNDER THIS PMA AND ITS SUPPLEMENTS
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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 |