Sofmed breathables XW Extended Parameters, Sofmed breathables XW toric Extended Parameters
FDA premarket approval P080011/S144 · decided 2022-08-15
Approval details
- PMA number
- P080011
- Supplement
- S144
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Sofmed breathables XW Extended Parameters, Sofmed breathables XW toric Extended Parameters
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2022-04-01
- Decision date
- 2022-08-15
- Days to decision
- 136 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Approval for a trade name change for CooperVision comfilcon A soft (hydrophilic) contact lenses for extended wear: Sofmed breathables XW Extended Parameters and Sofmed breathables XW toric Extended Parameters.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.