PMA P110007S005

Device: AMO HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD),(3% SODIUM HYALURONATE)
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P110007
Supplement: S005
Product code: LZP
Decision date: 2013-06-27
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: CONVERSION OF AN EXISTING CLEAN ROOM SPACE INTO AN ADDITIONAL FORMULATION ROOM FOR THE USE IN THE PRODUCTION OF THE HEALON ENDOCOAT OVD.

Current openFDA PMA Record#

Device: AMO HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD),(3% SODIUM HYALURONATE)
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P110007
Supplement: S005
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2013-06-27
Decision code: OK30
Date received: 2013-05-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CONVERSION OF AN EXISTING CLEAN ROOM SPACE INTO AN ADDITIONAL FORMULATION ROOM FOR THE USE IN THE PRODUCTION OF THE HEALON ENDOCOAT OVD.