PMA P980044S064

Device: SUPARTZ FX
Applicant: Seikagaku Corp.
PMA number: P980044
Supplement: S064
Product code: MOZ
Decision date: 2025-08-18
Classification: Orthopedic
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: for the sharing of existing SUPARTZ device family manufacturing equipment in Preparation Building-4 in the SKK Takahagi Plant for the manufacture of the FHA-SUPARTZ device family using hyaluronic acid derived from bacterial fermentation

Current openFDA PMA Record#

Device: SUPARTZ FX
Applicant: Seikagaku Corp.
PMA number: P980044
Supplement: S064
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2025-08-18
Decision code: OK30
Date received: 2025-07-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for the sharing of existing SUPARTZ device family manufacturing equipment in Preparation Building-4 in the SKK Takahagi Plant for the manufacture of the FHA-SUPARTZ device family using hyaluronic acid derived from bacterial fermentation