PMA P810031S056

Device: HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVI
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P810031
Supplement: S056
Decision date: 2016-06-14
Approval order statement: Approval for an alternative secondary blister tray packaging configuration called drop pack for AMOs family of Healon® OVDs that incorporates a transition Tyvek® lid manufactured using DuPonts flash-spinning process.

Current openFDA PMA Record#

Device: HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVI
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P810031
Supplement: S056
Decision date: 2016-06-14
Decision code: APPR
Date received: 2015-12-17
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for an alternative secondary blister tray packaging configuration called drop pack for AMOs family of Healon® OVDs that incorporates a transition Tyvek® lid manufactured using DuPonts flash-spinning process.