HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES
FDA premarket approval P850079/S029 · decided 1998-07-02
Approval details
- PMA number
- P850079
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 1998-01-20
- Decision date
- 1998-07-02
- Days to decision
- 163 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- Approval for spherical and toric configurations (clear and visibility tinted) of methafilcon A hydrophilic contact lenses for extended wear manufactured by a cast-molding process by Aspect Vision Care, Ltd., Hamble, United Kingdom.
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