PERFLUORON
FDA premarket approval P950018/S007 · decided 2001-08-07
Approval details
- PMA number
- P950018
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PERFLUORON
- Generic name
- Fluid, intraocular
- Applicant
- Alcon Laboratories
- Date received
- 2001-07-13
- Decision date
- 2001-08-07
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- ELIMINATION OF FINISHED PRODUCT INTRAVITREAL TESTING FOR PERFLUORON AND REVISION OF THE "PURIFIED PERFLUORO-N-OCTANE ANALYTICAL TEST MONOGRAPH" REGARDING CALCULATION OF IMPURITIES. THE SPECIFICATION OF >=99.9% FOR PURIFIED PERFLUORO-N-OCTANE REMAINS UNCHANGED.
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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 |