BIOFINITY (COMFILCON A)
FDA premarket approval P080011/S041 · decided 2016-03-21
Approval details
- PMA number
- P080011
- Supplement
- S041
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOFINITY (COMFILCON A)
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2016-02-29
- Decision date
- 2016-03-21
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Expansion of the cylinder powers available for Biofinity XR toric 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.