iWear oxygen presbyopia
FDA premarket approval P080011/S186 · decided 2025-08-20
Approval details
- PMA number
- P080011
- Supplement
- S186
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- iWear oxygen presbyopia
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2025-03-14
- Decision date
- 2025-08-20
- Days to decision
- 159 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- approval for labeling change to add new private label brand name, iWear oxygen presbyopia. The name iWear oxygen presbyopia is intended for the multifocal lens design
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.