O.P.R. -55 SOFT CONTACT LENS
FDA premarket approval P890053/S001 · decided 1990-03-06
Approval details
- PMA number
- P890053
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- O.P.R. -55 SOFT CONTACT LENS
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- N & N Contact Lens Co., Ltd.
- Date received
- 1989-10-18
- Decision date
- 1990-03-06
- Days to decision
- 139 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Lynwood, WA
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.