PMA N16895S099
- Device
- SofLens (polymacon) Visibility Tinted Contact Lens
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- N16895
- Supplement
- S099
- Product code
- LPM
- Decision date
- 2016-12-27
- Classification
- Lenses, Soft Contact, Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Approval to add a low temperature storage symbol on the Soflens 38 Contact lens finished product labeling.
Current openFDA PMA Record#
- Device
- SofLens (polymacon) Visibility Tinted Contact Lens
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- N16895
- Supplement
- S099
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2016-12-27
- Decision code
- APPR
- Date received
- 2016-07-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to add a low temperature storage symbol on the Soflens 38 Contact lens finished product labeling.