PMA P960028S040
- Device
- ReZoom 3-Piece Multifocal IOL
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P960028
- Supplement
- S040
- Product code
- MFK
- Decision date
- 2017-10-27
- Generic name
- Lens, multifocal intraocular
- Approval order statement
- Change to the acceptance criteria and inspection test method for the intraocular lens material.
Current openFDA PMA Record#
- Device
- ReZoom 3-Piece Multifocal IOL
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P960028
- Supplement
- S040
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2017-10-27
- Decision code
- OK30
- Date received
- 2017-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the acceptance criteria and inspection test method for the intraocular lens material.