Sofmed Toric Weeklies
FDA premarket approval P890023/S025 · decided 2016-09-22
Approval details
- PMA number
- P890023
- Supplement
- S025
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Sofmed Toric Weeklies
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2016-04-13
- Decision date
- 2016-09-22
- Days to decision
- 162 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for the addition of a new private label brand name Sofmed Toric Weeklies.
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