METHAFILCON A
FDA premarket approval P850079/S034 · decided 2000-05-05
Approval details
- PMA number
- P850079
- Supplement
- S034
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- METHAFILCON A
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2000-02-02
- Decision date
- 2000-05-05
- Days to decision
- 93 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- Approval of a protocol to extend the shelf life of methafilcon A blister packaged products from three years to six years.
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