PMA P790020S058

Device: PERMAFLEX NATURALS (SURFILCON A) AND PERMAFLEX UV NATURALS (VASURFILCON A) HYDROPHILIC CONTACT LENSES
Applicant: Advanced Medical Optics, Inc.
PMA number: P790020
Supplement: S058
Product code: LPM
Decision date: 1998-07-09
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Requested 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: PERMAFLEX NATURALS (SURFILCON A) AND PERMAFLEX UV NATURALS (VASURFILCON A) HYDROPHILIC CONTACT LENSES
Applicant: Advanced Medical Optics, Inc.
PMA number: P790020
Supplement: S058
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 the device which is terminally sterilized by steam sterilization, be released into distribution using parametric criteria rather than the existing Biological Indicators.