PMA P080011S088
- Device
- comfilcon A
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S088
- Product code
- LPM
- Decision date
- 2019-01-28
- Classification
- Lenses, Soft Contact, Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Introduction and validation of a new secondary packaging line at the CooperVision Manufacturing, Inc., labeling and packaging facility at West Henrietta, New York.
Current openFDA PMA Record#
- Device
- comfilcon A
- Applicant
- CooperVision, Inc.
- PMA number
- P080011
- Supplement
- S088
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2019-01-28
- Decision code
- OK30
- Date received
- 2019-01-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction and validation of a new secondary packaging line at the CooperVision Manufacturing, Inc., labeling and packaging facility at West Henrietta, New York.