PMA P910056S043
- Device
- enVista One-Piece Hydrophobic Acrylic Toric Intraoculer Lens (IOL)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P910056
- Supplement
- S043
- Product code
- HQL
- Decision date
- 2020-05-19
- Generic name
- intraocular lens
- Approval order statement
- Approval for an alternate packaging configuration for the IOL along with the designation as Model MX60PT.
Current openFDA PMA Record#
- Device
- enVista One-Piece Hydrophobic Acrylic Toric Intraoculer Lens (IOL)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P910056
- Supplement
- S043
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2020-05-19
- Decision code
- APPR
- Date received
- 2020-02-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an alternate packaging configuration for the IOL along with the designation as Model MX60PT.