PMA P890040
- Device
- SOFT-FORM 55EW; LL-55; SOFTCON EW2
- Applicant
- Unilens Corp., USA
- PMA number
- P890040
- Supplement
- S008
- Product code
- LPM
- Decision date
- 2016-02-29
- Classification
- Lenses, Soft Contact, Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Increase to the sterilization load size to utilize more of the chamber capacity.
Current openFDA PMA Record#
- Device
- SOFT-FORM 55EW; LL-55; SOFTCON EW2
- Applicant
- Unilens Corp., USA
- PMA number
- P890040
- Supplement
- S008
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2016-02-29
- Decision code
- OK30
- Date received
- 2016-02-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Increase to the sterilization load size to utilize more of the chamber capacity.