PMA N16895S096
- Device
- SOFLENS (POLYMACON) VISIBILITY TINTED CONTACT LENS
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- N16895
- Supplement
- S096
- Product code
- LPM
- Decision date
- 2014-10-02
- Classification
- Lenses, Soft Contact, Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- ADDITION OF AN ALTERNATE AUTOCLAVE FOR TERMINALLY STERILIZING SOFLENS® CONTACT LENSES.
Current openFDA PMA Record#
- Device
- SOFLENS (POLYMACON) VISIBILITY TINTED CONTACT LENS
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- N16895
- Supplement
- S096
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2014-10-02
- Decision code
- OK30
- Date received
- 2014-09-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ALTERNATE AUTOCLAVE FOR TERMINALLY STERILIZING SOFLENS® CONTACT LENSES.