VISCOAT VISCOELASTIC SYSTEM
FDA premarket approval P840064/S015 · decided 1996-03-22
Approval details
- PMA number
- P840064
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISCOAT VISCOELASTIC SYSTEM
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Alcon Laboratories
- Date received
- 1995-08-14
- Decision date
- 1996-03-22
- Days to decision
- 221 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR: 1)ALTERNATE MANUFACTURING SITE AT PUURS, BELGIUM; 2)USE OF 100% ETHYLENE OXIDE IN THE STERILIZATION PROCESS; AND 3)INCREASE IN THE ALLOWABLE FILL VOLUME TO 0.75 ML (THIS WAS INADVERTENTLY NOT INCLUDED IN OUR APPROVABLE LETTER OF 13-FEB-96)
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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 |