EXPRESSIONS (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES
FDA premarket approval P850079/S039 · decided 2002-01-17
Approval details
- PMA number
- P850079
- Supplement
- S039
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- EXPRESSIONS (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2001-12-06
- Decision date
- 2002-01-17
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- APPROVAL FOR AN ALTERNATE FACILITY FOR PAD PRINTING LOCATED AT ASPECT VISION CARE, SOUTHAMPTON, UNITED KINGDOM.
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