OPHTHALMIC VICOSURGICAL DEVICE (OVD)
FDA premarket approval P840064/S064 · decided 2017-10-25
Approval details
- PMA number
- P840064
- Supplement
- S064
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OPHTHALMIC VICOSURGICAL DEVICE (OVD)
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Alcon Laboratories
- Date received
- 2017-02-01
- Decision date
- 2017-10-25
- Days to decision
- 266 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for the use of Alcon Ireland Cork (AIC) as an alternative supplier of the cannula component to be used as part of the finished Ophthalmic Viscosurgical Devices (OVDs) at Alcon-Couvreur (Purrs) manufacturing facility.
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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 |