Biomedics 55 Asphere (ocufilcon D) Extended Wear Soft Contact Lenses
FDA premarket approval P890023/S040 · decided 2019-12-18
Approval details
- PMA number
- P890023
- Supplement
- S040
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biomedics 55 Asphere (ocufilcon D) Extended Wear Soft Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2019-12-03
- Decision date
- 2019-12-18
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Implementation of the manufacture of Biomedics 55 Asphere with a base curve of 8.9 mm in the Scottsville facility.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.