PMA P850079S072

Device: METHAFILCON A SOFT HYDROPHILIC EXTENDED WEAR CONTACT LENSES
Applicant: CooperVision, Inc.
PMA number: P850079
Supplement: S072
Product code: LPM
Decision date: 2017-02-13
Generic name: Lenses, soft contact, extended wear
Approval order statement: Use of Getinge autoclave A as back up equipment for the sterilization of lathing produced products (3 pack Blisters and Vials) in the event of breakdown or service of lathing autoclaves K and M at the CooperVision, Inc. Hamble UK manufacturing facility.

Current openFDA PMA Record#

Device: METHAFILCON A SOFT HYDROPHILIC EXTENDED WEAR CONTACT LENSES
Applicant: CooperVision, Inc.
PMA number: P850079
Supplement: S072
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2017-02-13
Decision code: OK30
Date received: 2017-01-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Use of Getinge autoclave A as back up equipment for the sterilization of lathing produced products (3 pack Blisters and Vials) in the event of breakdown or service of lathing autoclaves K and M at the CooperVision, Inc. Hamble UK manufacturing facility.