HYDRASOFT (METHAFILCON A) CONTACT LENS
FDA premarket approval P850079/S003 · decided 1986-11-12
Approval details
- PMA number
- P850079
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HYDRASOFT (METHAFILCON A) CONTACT LENS
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- CooperVision, Inc.
- Date received
- 1986-07-18
- Decision date
- 1986-11-12
- Days to decision
- 117 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
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