PMA P080011S067
- Device
- AquaClear Premium
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S067
- Product code
- LPM
- Decision date
- 2018-04-09
- Classification
- Lenses, Soft Contact, Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Approval for the addition of a new private label brand name, AquaClear Premium.
Current openFDA PMA Record#
- Device
- AquaClear Premium
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S067
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2018-04-09
- Decision code
- APPR
- Date received
- 2017-12-26
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of a new private label brand name, AquaClear Premium.