PMA P110007S003

Device: HEALON ENDOCOAT OPHTHALMIC VISCOELASTIC DEVICES (OVD)
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P110007
Supplement: S003
Product code: LZP
Decision date: 2013-05-28
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: APPROVAL FOR THE USE OF A NEW RAW MATERIAL SUPPLIER FOR THE NUTRIENT SOURCE USED IN THE SODIUM HYALURONATE MANUFACTURING PROCESS.

Current openFDA PMA Record#

Device: HEALON ENDOCOAT OPHTHALMIC VISCOELASTIC DEVICES (OVD)
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P110007
Supplement: S003
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2013-05-28
Decision code: APPR
Date received: 2013-04-01
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE USE OF A NEW RAW MATERIAL SUPPLIER FOR THE NUTRIENT SOURCE USED IN THE SODIUM HYALURONATE MANUFACTURING PROCESS.