PMA P810018S036
- Device
- Uv Absorbing Posterior Chamber Iol
- Applicant
- ALCON LABORATORIES
- PMA number
- P810018
- Supplement
- S036
- Decision date
- 1998-09-04
Current openFDA PMA Record
- Device
- UV ABSORBING POSTERIOR CHAMBER IOL
- Applicant
- Alcon Laboratories
- PMA number
- P810018
- Supplement
- S036
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 1998-09-04
- Decision code
- APPR
- Date received
- 1996-08-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an alternate sterilization process using 100% ethylene oxide, an alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."