Sofmed® breathables XW NEXT
FDA premarket approval P080011/S191 · decided 2025-12-05
Approval details
- PMA number
- P080011
- Supplement
- S191
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Sofmed® breathables XW NEXT
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2025-07-18
- Decision date
- 2025-12-05
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- re-branding of the Biofinity® (comfilcon A) Soft Contact Lenses for Extended Wear to the new private label trade name Sofmed® breathables XW NEXT.
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