PMA P960039
- Device
- SOFTCON EW 2 & SOFT-55 EW APHAKIC SOFT CONTACT LENSES
- Applicant
- Unilens Corporation, USA
- PMA number
- P960039
- Supplement
- S003
- Product code
- LPM
- Decision date
- 2008-03-03
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- APPROVAL TO BEGIN PARAMETRIC RELEASE FOR HYDROPHILIC LENSES PACKAGED IN VIALS.
Current openFDA PMA Record#
- Device
- SOFTCON EW 2 & SOFT-55 EW APHAKIC SOFT CONTACT LENSES
- Applicant
- Unilens Corporation, USA
- PMA number
- P960039
- Supplement
- S003
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2008-03-03
- Decision code
- APPR
- Date received
- 2007-12-31
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO BEGIN PARAMETRIC RELEASE FOR HYDROPHILIC LENSES PACKAGED IN VIALS.