SOFLENS (POLYMACON) CONTACT LENSES
FDA premarket approval N16895/S084 · decided 1997-01-30
Approval details
- PMA number
- N16895
- Supplement
- S084
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SOFLENS (POLYMACON) CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 1996-10-01
- Decision date
- 1997-01-30
- Days to decision
- 121 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR LABELING MODIFICTIONS TO SOFLENS(R) (POLYMACON) CONTACT LENSES INCLUDING THE FOLLOWING LENS TYPES (SERIES): 03, 04, OCCASIONS(TM) MULTIFOCAL, OPTIMA(TM) 38, OPTIMA(TM) 38/SP, U3, U4, SOFSPIN(TM), H03, H04, B3, B4, P.A.1, F3, H3, H4, N, NATURALTINE, OPTIMA(TM) FW, AND SEEQUENCE(TM). MODIFICATIONS INCLUDE: 1)REMOVING THE REPLACEMENT SYSTEM DESCRIPTORS FROM LABELING SPECIFIC TO THE OPTIMA(TM) FW CONTACT LENSES; 2)ADDING MONOVISIO FITTING TECHNIQUE FOR ALL BAUSCH & LOMB SOFLENS(R) (POLY
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