PMA P200020S004
- Device
- Rotlex IOLA MFD
- Applicant
- Lenstec, Inc.
- PMA number
- P200020
- Supplement
- S004
- Product code
- MFK
- Decision date
- 2023-11-09
- Classification
- Ophthalmic
- Generic name
- Lens, multifocal intraocular
- Approval order statement
- to add an additional lens analyzer for the manufacture of the SBL-3 intraocular lens
Current openFDA PMA Record#
- Device
- Rotlex IOLA MFD
- Applicant
- Lenstec, Inc.
- PMA number
- P200020
- Supplement
- S004
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2023-11-09
- Decision code
- OK30
- Date received
- 2023-10-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add an additional lens analyzer for the manufacture of the SBL-3 intraocular lens