PMA N16895S097
- Device
- SOFLENS (POLYMACON) VISIBILITY TINTED CONTACT LENS
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- N16895
- Supplement
- S097
- Product code
- LPM
- Decision date
- 2015-08-19
- Classification
- Lenses, Soft Contact, Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- USE OF A MORE PURIFIED FORM OF THE RAW MATERIAL ANDIMPLEMENTATION FOR A TIGHTENED RAW MATERIAL PURITY SPECIFICATION.
Current openFDA PMA Record#
- Device
- SOFLENS (POLYMACON) VISIBILITY TINTED CONTACT LENS
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- N16895
- Supplement
- S097
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2015-08-19
- Decision code
- OK30
- Date received
- 2015-08-03
- Supplement type
- 30-Day Notice
- Approval order statement
- USE OF A MORE PURIFIED FORM OF THE RAW MATERIAL ANDIMPLEMENTATION FOR A TIGHTENED RAW MATERIAL PURITY SPECIFICATION.