AOSEPT (R) LENS CUP & AODISC NEUTRALIZER
FDA premarket approval P820040/S032 · decided 1995-10-23
Approval details
- PMA number
- P820040
- Supplement
- S032
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AOSEPT (R) LENS CUP & AODISC NEUTRALIZER
- Generic name
- Accessories, soft lens products
- Applicant
- Ciba Vision Care
- Date received
- 1994-09-08
- Decision date
- 1995-10-23
- Days to decision
- 410 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Duluth, GA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE CURRENTLY APPROVED AOSEPT LENS CUP AND AODISC NEUTRALIZER TO INLCUDE A CUP MANUFACTURING SITE CHANGE, CUP MATERIAL CHANGE, CUP AND DISC DESIGN CHANGE, AND CORRESPONDING LABELING CHANGES. THE NEW PRIMARY MANUFACTURING SITE IS TENAX CORPORATION, 124 FRANKLIN PARK AVENUE, YOUNGSVILLE, NC 27596. SECONDARY MANUFACTURING SITE IS TENAX CORP, 2450 LAURA DUNCAN ROAD, APEX, NC 27502
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PROFESSIONAL DISINFECTION SYSTEM (PDS) (K863346) | Ciba Vision Care | 1987-02-27 |
| IN A WINK LUBRICATING & REWETTING DROPS (K853445) | Ciba Vision Care | 1985-11-29 |