PMA P960039S001

Device: SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)
Applicant: Unilens Corporation, USA
PMA number: P960039
Supplement: S001
Product code: LPM
Decision date: 1998-07-09
Generic name: Lenses, soft contact, extended wear
Approval order statement: Requested that the device which is terminally sterilized by steam sterilization, be released into distribution using parametric criteria rather than the existing Biological Indicators.

Current openFDA PMA Record#

Device: SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)
Applicant: Unilens Corporation, USA
PMA number: P960039
Supplement: S001
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 1998-07-09
Decision code: OK30
Date received: 1998-06-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Requested that the device which is terminally sterilized by steam sterilization, be released into distribution using parametric criteria rather than the existing Biological Indicators.