PMA P960028S038
- Device
- REZOOM 3-PC MULTIFOCAL
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P960028
- Supplement
- S038
- Product code
- MFK
- Decision date
- 2016-01-12
- Generic name
- Lens, multifocal intraocular
- Approval order statement
- TO ADD 2 NEW CONTRACTORS TO PURIFY THE MONOMERS AND CROSS-LINKERS TO PRODUCE THE SILICONE MATERIAL USED IN THE ABOVE INTRAOCULAR LENSES.
Current openFDA PMA Record#
- Device
- REZOOM 3-PC MULTIFOCAL
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P960028
- Supplement
- S038
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2016-01-12
- Decision code
- OK30
- Date received
- 2015-12-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- TO ADD 2 NEW CONTRACTORS TO PURIFY THE MONOMERS AND CROSS-LINKERS TO PRODUCE THE SILICONE MATERIAL USED IN THE ABOVE INTRAOCULAR LENSES.