PMA P080020S056

Device: Gel-One
Applicant: Seikagaku Corp.
PMA number: P080020
Supplement: S056
Product code: MOZ
Decision date: 2026-09-04
Classification: Orthopedic
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: Approval to replace one of two existing isolators used for sterility testing of Gel-One with a new isolator equipped with an integrated hydrogen peroxide decontamination system.

Current openFDA PMA Record#

Device: Gel-One
Applicant: Seikagaku Corp.
PMA number: P080020
Supplement: S056
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2026-09-04
Decision code: APPR
Date received: 2026-07-07
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to replace one of two existing isolators used for sterility testing of Gel-One with a new isolator equipped with an integrated hydrogen peroxide decontamination system.