PMA P880072S036

Device: MODIFIED J-LOOP POSTERIOR CHAMBER IOL
Applicant: Eyekon Medical, Inc.
PMA number: P880072
Supplement: S036
Product code: HQL
Decision date: 1996-02-12
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: APPROVAL FOR AN ALTERNATE CONTRACT STERILIZER, MEDICAL MANUFACTURING CORP., AT 2205 EAST 33RD STREET, ERIE, PA 16510, AND CONVERSION FROM 12/88 ETHYLENE OXIDE (ETO)/FREON TO 100% ETO STERILIZATION

Current openFDA PMA Record#

Device: MODIFIED J-LOOP POSTERIOR CHAMBER IOL
Applicant: Eyekon Medical, Inc.
PMA number: P880072
Supplement: S036
Product code: HQL
Generic name: intraocular lens
Decision date: 1996-02-12
Decision code: APPR
Date received: 1995-08-25
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR AN ALTERNATE CONTRACT STERILIZER, MEDICAL MANUFACTURING CORP., AT 2205 EAST 33RD STREET, ERIE, PA 16510, AND CONVERSION FROM 12/88 ETHYLENE OXIDE (ETO)/FREON TO 100% ETO STERILIZATION