METHAFILCON A
FDA premarket approval P850079/S030 · decided 1999-04-15
Approval details
- PMA number
- P850079
- Supplement
- S030
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- METHAFILCON A
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 1999-03-11
- Decision date
- 1999-04-15
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- Approval for an alternate tinting process, In-Monomer-Tinting Process.
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