PMA P850079
- Device
- Hydrasoft (methafilcon B) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Applicant
- CooperVision, Inc.
- PMA number
- P850079
- Supplement
- S089
- Product code
- LPM
- Decision date
- 2020-09-01
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- New water treatment system in the Scotsville facility as part of the facility renovation project.
Current openFDA PMA Record#
- Device
- Hydrasoft (methafilcon B) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Applicant
- CooperVision, Inc.
- PMA number
- P850079
- Supplement
- S089
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2020-09-01
- Decision code
- OK30
- Date received
- 2020-08-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New water treatment system in the Scotsville facility as part of the facility renovation project.