PMA P980044S067

Device: SUPARTZ FX
Applicant: Seikagaku Corp.
PMA number: P980044
Supplement: S067
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 SUPARTZ FX with a new isolator equipped with an integrated hydrogen peroxide decontamination system.

Current openFDA PMA Record#

Device: SUPARTZ FX
Applicant: Seikagaku Corp.
PMA number: P980044
Supplement: S067
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2026-09-04
Decision code: APPR
Date received: 2026-07-06
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 SUPARTZ FX with a new isolator equipped with an integrated hydrogen peroxide decontamination system.