PMA P910061S019
- Device
- SOFLEX & SOFPORT POSTERIOR CHAMBER INTRAOCULAR LENSES
- Applicant
- Bausch & Lomb
- PMA number
- P910061
- Supplement
- S019
- Product code
- HQL
- Decision date
- 2009-12-02
- Classification
- Intraocular Lens
- Generic name
- intraocular lens
- Approval order statement
- CHANGE IN THE BIOLOGICAL INDICATOR TESTING SITE FROM ALLIANCE MEDICAL PRODUCTS IN IRVINE, CALIFORNIA TO THE BAUSCH & LOMB FACILITY IN TAMPA, FLORIDA.
Current openFDA PMA Record#
- Device
- SOFLEX & SOFPORT POSTERIOR CHAMBER INTRAOCULAR LENSES
- Applicant
- Bausch & Lomb
- PMA number
- P910061
- Supplement
- S019
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2009-12-02
- Decision code
- OK30
- Date received
- 2009-11-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE BIOLOGICAL INDICATOR TESTING SITE FROM ALLIANCE MEDICAL PRODUCTS IN IRVINE, CALIFORNIA TO THE BAUSCH & LOMB FACILITY IN TAMPA, FLORIDA.