comfilcon A Soft (Hydrophilic) Contact Lenses for Extended Wear
FDA premarket approval P080011/S203 · decided 2026-07-07
Approval details
- PMA number
- P080011
- Supplement
- S203
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- comfilcon A Soft (Hydrophilic) Contact Lenses for Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2026-06-15
- Decision date
- 2026-07-07
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- update a raw material specification, introduce an incoming inspection test method, and modify an existing incoming inspection test method at the facilities in Hamble, United Kingdom, Scottsville, New York, and Juana Diaz, Puerto Rico
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.