BIOMEDICS UV 55% (OCUFILCON D) SPHERE, ASPHERE & TORIC SOFT CONTACT LENS
FDA premarket approval P890023/S017 · decided 2011-08-09
Approval details
- PMA number
- P890023
- Supplement
- S017
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOMEDICS UV 55% (OCUFILCON D) SPHERE, ASPHERE & TORIC SOFT CONTACT LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2010-04-26
- Decision date
- 2011-08-09
- Days to decision
- 470 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR AN ALTERNATE VENDOR, BIMAX, FOR RAW MATERIAL.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.