TIER A & B INTRAOCULAR LENSES
FDA premarket approval P890068/S001 · decided 1993-10-22
Approval details
- PMA number
- P890068
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TIER A & B INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Chiron Ophthalmics
- Date received
- 1991-01-24
- Decision date
- 1993-10-22
- Days to decision
- 1002 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MEDILENS-CS CORNEAL SHIELD (K915861) | Chiron Ophthalmics | 1992-03-06 |
| CHIROFLEX II LENS MICROSERT(TM) (K914311) | Chiron Ophthalmics | 1992-01-27 |
| COLLAGEN SHIELD, VARIOUS MODELS (K905825) | Chiron Ophthalmics | 1991-06-10 |
| CHIROFLEX FORCEPS (K903575) | Chiron Ophthalmics | 1990-12-21 |
| CHIROFLEX LENS MICROSERT (K903574) | Chiron Ophthalmics | 1990-09-17 |
| MEDILENS(TM) CORNEAL SHIELD (K901880) | Chiron Ophthalmics | 1990-07-02 |
| OPTISOL (K894162) | Chiron Ophthalmics | 1990-01-12 |
| COI 72 HR COLLAGEN SHIELD (K885015) | Chiron Ophthalmics | 1989-06-23 |