PMA P810031S059

Device: HEALON DUET DUAL PACK
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P810031
Supplement: S059
Product code: LZP
Decision date: 2017-10-31
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: Approval for a manufacturing site located at Lifecore Biomedical, LLC, 1245 Lakeview Drive Chaska, Minnesota to be used for post-sterilization final packaging,warehousing, and distribution activities.

Current openFDA PMA Record#

Device: HEALON DUET DUAL PACK
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P810031
Supplement: S059
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2017-10-31
Decision code: APPR
Date received: 2016-11-14
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Lifecore Biomedical, LLC, 1245 Lakeview Drive Chaska, Minnesota to be used for post-sterilization final packaging,warehousing, and distribution activities.