PMA P800049
- Device
- Iridocapsular Intraocular Lens
- Applicant
- ALCON
- PMA number
- P800049
- Supplement
- S008
- Decision date
- 1998-09-04
Current openFDA PMA Record
- Device
- IRIDOCAPSULAR INTRAOCULAR LENS
- Applicant
- Alcon
- PMA number
- P800049
- Supplement
- S008
- 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 resteriliztion in the event of an "aborted cycle."