PMA P860034S013
- Device
- MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL
- Applicant
- Advanced Medical Optics, Inc.
- PMA number
- P860034
- Supplement
- S013
- Product code
- HQL
- Decision date
- 1997-10-07
- Generic name
- intraocular lens
- Approval order statement
- Approval to modify the current maximum level of ethylene oxide residual from "not to exceed 25 ppm" to "not to exceed 1.0 ug/lens."
Current openFDA PMA Record#
- Device
- MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL
- Applicant
- Advanced Medical Optics, Inc.
- PMA number
- P860034
- Supplement
- S013
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 1997-10-07
- Decision code
- APPR
- Date received
- 1995-11-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to modify the current maximum level of ethylene oxide residual from "not to exceed 25 ppm" to "not to exceed 1.0 ug/lens."