PMA P840064S056

Device: VISCOAT, DUOVISC,DISCOVISC
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S056
Product code: LZP
Decision date: 2014-04-29
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: USE OF A NEW RAW MATERIAL IN THE RUBBER FORMULATION OF THE TIP CAPS USED FOR THEIR VISCOAT, DUOVISC, DISCOVISC, AND PROVISC OVD. THE SUBMISSION ALSO REQUESTED A MATERIALADDITION TO OPTIMIZE THE PLACEMENT OF THE TIP CAP FOR THE VISCOAT.

Current openFDA PMA Record#

Device: VISCOAT, DUOVISC,DISCOVISC
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S056
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2014-04-29
Decision code: OK30
Date received: 2014-04-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: USE OF A NEW RAW MATERIAL IN THE RUBBER FORMULATION OF THE TIP CAPS USED FOR THEIR VISCOAT, DUOVISC, DISCOVISC, AND PROVISC OVD. THE SUBMISSION ALSO REQUESTED A MATERIALADDITION TO OPTIMIZE THE PLACEMENT OF THE TIP CAP FOR THE VISCOAT.