Sofmed brethables XW, Sofmed breathables XW premium, Sofmed breathables XW toric, Sofmed breathables XW multifocal
FDA premarket approval P080011/S068 · decided 2018-04-25
Approval details
- PMA number
- P080011
- Supplement
- S068
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Sofmed brethables XW, Sofmed breathables XW premium, Sofmed breathables XW toric, Sofmed breathables XW multifocal
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2018-01-11
- Decision date
- 2018-04-25
- Days to decision
- 104 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Approved for the addition of a new private label brand name Sofmed breathables XW (comfilcon A), Sofmed breathables XW premium (comfilcon A), Sofmed breathables XW toric (comfilcon A) and Sofmed breathables XW multifocal (comfilcon A) Soft Extended Wear Contact Lenses.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.