CABCURVE (POROFOCAN B)
FDA premarket approval N18032/S006 · decided 1983-10-25
Approval details
- PMA number
- N18032
- Supplement
- S006
- Trade name
- CABCURVE (POROFOCAN B)
- Generic name
- Lens, contact (polymethylmethacrylate)
- Applicant
- Wesley Jessen Corp.
- Date received
- 1983-04-05
- Decision date
- 1983-10-25
- Days to decision
- 203 days
- Decision code
- APPR
- Product code
- HPX
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Des Plaines, IL
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.