PMA P810031S052

Device: SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P810031
Supplement: S052
Product code: LZP
Decision date: 2015-04-02
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: MODIFY THE QUALITY CONTROL TEST METHODS AND/OR ACCEPTANCE CRITERIA ASSOCIATED WITH THE ABBOTT MEDICAL OPTICS (AMO) SODIUM HAYALURONATE (NAHY) SPECIFICATIONS.

Current openFDA PMA Record#

Device: SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P810031
Supplement: S052
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2015-04-02
Decision code: OK30
Date received: 2015-02-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MODIFY THE QUALITY CONTROL TEST METHODS AND/OR ACCEPTANCE CRITERIA ASSOCIATED WITH THE ABBOTT MEDICAL OPTICS (AMO) SODIUM HAYALURONATE (NAHY) SPECIFICATIONS.