PMA P840031S009

Device: LL-79 LIDOFILCON B (HYDROPHILIC) CONTACT LENS
Applicant: Lombart Lenses, Ltd.
PMA number: P840031
Supplement: S009
Product code: LPM
Decision date: 1998-07-09
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: The 30-day Notice 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: LL-79 LIDOFILCON B (HYDROPHILIC) CONTACT LENS
Applicant: Lombart Lenses, Ltd.
PMA number: P840031
Supplement: S009
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: The 30-day Notice requested that the device, which is terminally sterilized by steam sterilization, be released into distribution using parametric criteria rather than the existing Biological Indicators.