PMA P850079S067

Device: FREQUENCY (METHAFILCON A AND B) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES
Applicant: CooperVision, Inc.
PMA number: P850079
Supplement: S067
Product code: LPM
Decision date: 2014-09-09
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: REPLACEMENT OF THE FEDEGARI THERMA 3 FOAF3 AUTOCLAVE (FEDEGARI W) WITH THERMA 4 FOAF3/A FEDEGARI AUTOCLAVE (FEDEGARI F).

Current openFDA PMA Record#

Device: FREQUENCY (METHAFILCON A AND B) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES
Applicant: CooperVision, Inc.
PMA number: P850079
Supplement: S067
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2014-09-09
Decision code: OK30
Date received: 2014-08-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REPLACEMENT OF THE FEDEGARI THERMA 3 FOAF3 AUTOCLAVE (FEDEGARI W) WITH THERMA 4 FOAF3/A FEDEGARI AUTOCLAVE (FEDEGARI F).