PMA P810031S064

Device: Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon, Healon GV, Healon5, Healon Ultimate Dual Pack, Healon
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P810031
Supplement: S064
Product code: LZP
Decision date: 2018-02-27
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: Tightening of the endotoxin specification from 0.5 EU/ml to 0.2 EU/ml, an alternate Limulus Amebocyte Lysate (LAL) testing method, and a change to the sampling method for LAL testing for the Healon®, Healon5®, Healon GV®, Healon® Ultimate Dual Pack and Healon Duet® Dual Pack Ophthalmic Viscoelastic Devices (OVDs).

Current openFDA PMA Record#

Device: Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon, Healon GV, Healon5, Healon Ultimate Dual Pack, Healon
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P810031
Supplement: S064
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2018-02-27
Decision code: OK30
Date received: 2018-02-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Tightening of the endotoxin specification from 0.5 EU/ml to 0.2 EU/ml, an alternate Limulus Amebocyte Lysate (LAL) testing method, and a change to the sampling method for LAL testing for the Healon®, Healon5®, Healon GV®, Healon® Ultimate Dual Pack and Healon Duet® Dual Pack Ophthalmic Viscoelastic Devices (OVDs).