PMA P800049S008

Device: IRIDOCAPSULAR INTRAOCULAR LENS
Applicant: Alcon
PMA number: P800049
Supplement: S008
Product code: HQL
Decision date: 1998-09-04
Generic name: intraocular lens
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."

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."