HYDRASOFT METHAFILCON B
FDA premarket approval P850079/S027 · decided 1996-12-11
Approval details
- PMA number
- P850079
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HYDRASOFT METHAFILCON B
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 1996-06-19
- Decision date
- 1996-12-11
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- ALTERNATE MANUFACTURING PROCESS AND POLYMERIZATION METHOD
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