HYDRASOFT (METHAFILCON B) CONTACT LENS
FDA premarket approval P850079/S070 · decided 2016-03-09
Approval details
- PMA number
- P850079
- Supplement
- S070
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HYDRASOFT (METHAFILCON B) CONTACT LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2016-02-12
- Decision date
- 2016-03-09
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- Transfer of the frequency Xcel toric core cylinder powers -0.75, -1.25, -1.75 and -2.25D dry molding manufacturing process from Dry Line S to Dry Line 1.
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