PMA P810031S044

Device: SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5 PRODUCTS
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P810031
Supplement: S044
Product code: LZP
Decision date: 2012-04-18
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: CHANGE TO REPLACE REUSABLE GLASS SAMPLE TUBES WITH DISPOSABLE POLYPROPYLENE SAMPLE TUBES IN THE SODIUM HYALURONATE TEST METHOD.

Current openFDA PMA Record#

Device: SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5 PRODUCTS
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P810031
Supplement: S044
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2012-04-18
Decision code: OK30
Date received: 2012-03-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO REPLACE REUSABLE GLASS SAMPLE TUBES WITH DISPOSABLE POLYPROPYLENE SAMPLE TUBES IN THE SODIUM HYALURONATE TEST METHOD.