- Device
- AMO REZOOM INTRAOCULAR LENS (IOL) MODEL NXG1
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P960028
- Supplement
- S035
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2012-04-23
- Decision code
- APPR
- Date received
- 2011-11-14
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE IN THE TEST METHOD USED TO DETERMINE BACTERIAL ENDOTOXIN LEVELS OF INTRAOCULAR LENSES.