VISCOAT ORPHTHALMIC VISCOSURGICAL DEVICE
FDA premarket approval P840064/S023 · decided 2002-03-25
Approval details
- PMA number
- P840064
- Supplement
- S023
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VISCOAT ORPHTHALMIC VISCOSURGICAL DEVICE
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Alcon Laboratories
- Date received
- 2002-02-20
- Decision date
- 2002-03-25
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR ADDING SYRINGE ASSEMBLY ILLUSTRATIONS AND INSTRUCTIONS TO THE PROVISC PORTION OF THE DUOVISC INSERT TO ENHANCE THE SAFE USE OF THE DEVICE. THE PROVISC SYRINGE ASSEMBLY INSTRUCTIONS WILL STANDARDIZE INSTRUCTIONS WITHIN THE DUOVISC INSERT.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |