HYDRASOFT (METHAFILCON A) CONTACT LENS
FDA premarket approval P850079/S005 · decided 1986-11-18
Approval details
- PMA number
- P850079
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HYDRASOFT (METHAFILCON A) CONTACT LENS
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- CooperVision, Inc.
- Date received
- 1986-09-12
- Decision date
- 1986-11-18
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.