VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System, DISCOVISC Ophthalmic Viscosurgical
FDA premarket approval P840064/S085 · decided 2024-06-17
Approval details
- PMA number
- P840064
- Supplement
- S085
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System, DISCOVISC Ophthalmic Viscosurgical
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Alcon Laboratories
- Date received
- 2024-05-20
- Decision date
- 2024-06-17
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- to use a campaign filling strategy for the production of PROVISC Ophthalmic Viscosurgical Device, VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscoelastic System, and DISCOVISC Ophthalmic Viscosurgical Device OVDs at the Lifecore Biomedical manufacturing site
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| NEXT GENERATION LASER (K062624) | Alcon Laboratories | 2007-11-05 |
| SMALL VOLUME SYRINGE (K062865) | Alcon Laboratories | 2007-08-23 |
| RGP MULTI-PURPOSE SOLUTION ID 100136 (K000148) | Alcon Laboratories | 2000-04-11 |
| OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP (K984573) | Alcon Laboratories | 1999-09-16 |
| OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER (K990480) | Alcon Laboratories | 1999-05-10 |
| MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 (K984575) | Alcon Laboratories | 1999-01-14 |
| OPTI-ONE MULTI-PURPOSE SOLUTION (K983973) | Alcon Laboratories | 1998-12-18 |
| MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 (K983780) | Alcon Laboratories | 1998-12-18 |