ANTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P810001/S013 · decided 1998-09-04
Approval details
- PMA number
- P810001
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANTERIOR CHAMBER INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Alcon
- Date received
- 1996-08-08
- Decision date
- 1998-09-04
- Days to decision
- 757 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for an alternate sterilization process using 100% ethylene oxide, an alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ALCON VISION SYSTEM (K063583) | Alcon | 2008-05-09 |
| OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION (K981574) | Alcon | 1998-07-06 |