PMA P840060S042
- Device
- Single-Piece Posterior Chamber IOL
- Applicant
- Alcon Laboratories
- PMA number
- P840060
- Supplement
- S042
- Product code
- HQL
- Decision date
- 2017-03-03
- Generic name
- intraocular lens
- Approval order statement
- Approval to move the testing for bacterial endotoxins and microvacuoles from post-sterilization to pre-sterilization after device packaging.
Current openFDA PMA Record#
- Device
- Single-Piece Posterior Chamber IOL
- Applicant
- Alcon Laboratories
- PMA number
- P840060
- Supplement
- S042
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2017-03-03
- Decision code
- APPR
- Date received
- 2016-07-29
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to move the testing for bacterial endotoxins and microvacuoles from post-sterilization to pre-sterilization after device packaging.