HYDRASOFT KERATOCONUS METHAFILCON B
FDA premarket approval P850079/S025 · decided 1994-06-24
Approval details
- PMA number
- P850079
- Supplement
- S025
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HYDRASOFT KERATOCONUS METHAFILCON B
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- CooperVision, Inc.
- Date received
- 1994-05-04
- Decision date
- 1994-06-24
- Days to decision
- 51 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.