Hydrasoft (methafilcon B) Soft (Hydrophilic) Contact Lenses for Extended Wear
FDA premarket approval P850079/S089 · decided 2020-09-01
Approval details
- PMA number
- P850079
- Supplement
- S089
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Hydrasoft (methafilcon B) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2020-08-03
- Decision date
- 2020-09-01
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- New water treatment system in the Scotsville facility as part of the facility renovation project.
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